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Statement

Our company holds the copyrights to this manual, which is non-publicly published, and reserves
the rights to keep it as a secure document. Refer to this manual when operating, maintaining and
repairing products only. Anyone other than our company may not make it known to others.
Proprietary materials protected by the copyright law are included in this manual. Any section of it
cannot be reproduced, copied, or translated into other languages without any prior written
approval from our company who reserves the copyright.
Everything written in this manual is considered to be correct. Our company is not legally
responsible for any mistakes printed within and any damages caused by incorrect installation and
operation. Our company does not supply privileges endowed by the patent law to any other parties.
Our company is not legally responsible for the results caused by patent law breaking and any
rights of the third party violating.
Refer to this manual before the product is used. The manual includes operating procedures which
must be performed with cautiously, operations that may result in non-normal working conditions
and the dangers which may damage equipment or cause bodily harm. Our company is not
responsible for the security, reliability and function of the equipments in case that the dangers,
damages and non-normal phenomenon mentioned in this manual happen. Free repairs for these
malfunctions will not be provided by our company.
Our company has the rights to replace any content in this manual without notice.

Manufacturer Responsibility:
Our company responsible for the security, reliability and function of the equipments when to
following conditions are adhered to:
 Installation, adjustments, mending and repairs must be performed by individuals authorized
by our company;
 Necessary electrical equipment and the working environment must be in accordance with the
national standards, professional standards and the requirements listed in this manual;
 Equipment must be used as instructed in the operating instructions.
CAUTION: This equipment is not for family use.
CAUTION: Malfunctioning equipment may become invalid and cause bodily injury if a set
of effective and approving repairing proposals cannot be submitted by the
institution which is responsible for using this equipment.
The paid theoretical framework diagram will be supplied according to customer requirements by
our company, plus calibrating method and other information to help the customer, under the
assistance of qualified technicians, repair the equipment parts where can be done by customer
himself based on the stipulation by our company.

Warranty:
Manufacturing techniques and materials:
For a period of one year from the date of original delivery, the components and assemblies of this
product is warranted to be free from defects manufacturing techniques and materials, provided
that the same is properly operated under the conditions of normal use and regular maintenance.
The warranty period for other parts is three months. Expendable parts are not included. Our
obligation under the above warranties is limited to repairing free of charge.

i
User Manual

Free Obligations:
 Our obligation under the above warranties does not include the freight and other fees;
 Our company is not responsible for any direct, indirect or final product broken and delay which
result from improper use, alteration by using the assemblies unratified and maintenance by
anyone other than our company;
 This warranty does not apply to the followings:
 Improper use
 Machines without maintenance or machines broken
 The label of our original serial number or mark is removed or replaced
 Other manufacturers’ product

Security, reliability and operating condition:


Our company is not responsible for the security, reliability and operating condition of this product in
case that:
 The assemblies are disassembled, extended and readjusted
 This product is not operated correctly in accordance with the manual instruction. The power
supply used or operating environment does not follow the requirements in this manual.

Return
Follow the steps below in case that the product needs to be returned to our company:
1. Obtain the rights of return
Contact our customer service by informing them the number and type of the product. The number
is marked on the surface of the product. Return is unacceptable if the number cannot be identified.
Enclose a statement of the number, type and the reason of return as well.
2. Transportation charges
Transportation and insurance charges must be prepaid by the user for transporting the product to
our company for repairing. (Customers charges is added with regard to the products sold to
non-Chinese mainland users)

ii
Contents

1 Introduction ............................................................................................................................... 1—1


1.1 Intended Use ....................................................................................................................... 1—1
1.1.1 Range of use ................................................................................................................... 1—1
1.1.2 Contraindication ............................................................................................................... 1—1
1.2 Symbols ............................................................................................................................... 1—2
1.3 Definition, abbreviation ........................................................................................................ 1—3
2 System Components ................................................................................................................ 2—1
2.1 Anesthetic System ............................................................................................................... 2—1
2.2 Front View ........................................................................................................................... 2—2
2.3 Rear View ............................................................................................................................ 2—4
2.4 Breathing System ................................................................................................................ 2—5
2.5 Vaporizer ............................................................................................................................. 2—6
3 UI................................................................................................................................................. 3—1
3.1 Front Panel .......................................................................................................................... 3—1
3.1.1 Keys ................................................................................................................................. 3—2
3.1.2 Indicator ........................................................................................................................... 3—2
3.1.3 Navigator knob ................................................................................................................ 3—2
3.2 Screen Layout ..................................................................................................................... 3—3
3.2.1 Information Area .............................................................................................................. 3—4
3.2.2 Monitoring Area ............................................................................................................... 3—5
3.2.3 Parameters Setup Area ................................................................................................... 3—5
3.3 Rear Panel .......................................................................................................................... 3—6
3.4 Menu.................................................................................................................................... 3—7
3.4.1 Operating Guide .............................................................................................................. 3—7
4 Operating Guide ........................................................................................................................ 4—1
4.1 Startup ................................................................................................................................. 4—1
4.1.1 System Selftest ................................................................................................................ 4—1
4.1.2 Manual Leak Test ............................................................................................................ 4—3
4.1.3 Safety Valve Test ............................................................................................................. 4—4
4.1.4 Automatic Leak Test ........................................................................................................ 4—5
4.1.5 Compliance Test .............................................................................................................. 4—7
4.1.6 Ventilation Mode Setup.................................................................................................... 4—9
4.1.7 Breathing Parameters Setup ........................................................................................... 4—9
4.2 Start Mechanical Ventilation .............................................................................................. 4—10
4.2.1 Stop Mechanical Ventilation .......................................................................................... 4—10
4.3 Start Manual Ventilation .................................................................................................... 4—11
4.3.1 Stop Manual Ventilation ................................................................................................. 4—11
4.4 Shutdown .......................................................................................................................... 4—11
4.5 Waveforms ........................................................................................................................ 4—12
4.5.1 Paw-t waveform ............................................................................................................. 4—12
4.5.2 Flow-t waveform ............................................................................................................ 4—12
4.5.3 Pressure-Volume Loop .................................................................................................. 4—13
4.5.4 Flow-volume Loop ......................................................................................................... 4—13
5 Preuse Checkout ....................................................................................................................... 5—1
5.1 Preuse Checkout Procedure ............................................................................................... 5—1
5.1.1 Check System ................................................................................................................. 5—2
5.1.2 Power failure alarm test ................................................................................................... 5—2
5.2 Test gas supply pipeline and cylinder .................................................................................. 5—3
5.3 Monitoring Flow Control ...................................................................................................... 5—4
5.3.1 Monitoring without oxygen ............................................................................................... 5—4
5.3.2 Monitoring with Oxygen ................................................................................................... 5—7
5.4 Installing andTesting of Vaporizer........................................................................................ 5—9
5.4.1 Installation ....................................................................................................................... 5—9

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User Manual

5.4.2 Testing Vaporizer ............................................................................................................. 5—9


5.5 Alarm Test.......................................................................................................................... 5—10
5.6 Breathing System Test ...................................................................................................... 5—12
5.6.1 Check O2+ Button .......................................................................................................... 5—12
5.6.2 Testing Breathing System .............................................................................................. 5—12
5.6.3 APL Valve Test ............................................................................................................... 5—12
5.7 Ventilator Test .................................................................................................................... 5—12
6 Installation and Connection ..................................................................................................... 6—1
6.1 Installation ........................................................................................................................... 6—2
6.2 Install Absorber Canister ..................................................................................................... 6—3
6.2.1 When to Replace Absorbent ............................................................................................ 6—3
6.2.2 Disassembling Absorber .................................................................................................. 6—3
6.2.3 Filling Absorbent .............................................................................................................. 6—4
6.3 Connecting Tubes and Cables ............................................................................................ 6—5
6.4 Connecting Gas and Electricity ........................................................................................... 6—8
6.4.1 AC Inlet ............................................................................................................................ 6—8
6.4.2 Aux. Mains Outlet ............................................................................................................ 6—9
6.4.3 Serial Port ...................................................................................................................... 6—10
6.4.4 Gas Inlet Module ........................................................................................................... 6—10
6.4.5 Cylinder Yoke System.................................................................................................... 6—11
6.5 Install gas cylinder (Test high pressure leak) .................................................................... 6—12
6.6 Connect AGSS .................................................................................................................. 6—13
6.7 IRMA Probe specification .................................................................................................. 6—14
6.7.1 Intended use .................................................................................................................. 6—15
6.7.2 Technical specification ................................................................................................... 6—15
6.7.3 System assembly instruction ......................................................................................... 6—17
6.7.4 Zeroing procedure ......................................................................................................... 6—18
6.7.5 Alarms............................................................................................................................ 6—19
6.7.6 Cleaning ........................................................................................................................ 6—19
6.7.7 Preventive maintenance instructions ............................................................................. 6—19
6.7.8 Warnings ........................................................................................................................ 6—20
6.7.9 Cautions ........................................................................................................................ 6—20
6.7.10 Gas Module ............................................................................................................... 6—20
6.7.11 Settings on CO2 Module ............................................................................................ 6—21
6.7.12 CO2Module Calibration .............................................................................................. 6—22
6.7.13 Agent Module Calibration .......................................................................................... 6—24
7 Cleaning and Disinfecting ........................................................................................................ 7—1
7.1 Cleaning and Disinfection of Pre-use .................................................................................. 7—2
7.2 Cleanable Breathing System Components ......................................................................... 7—2
7.3 Absorber Canister ............................................................................................................... 7—2
7.3.1 Auto cleaning with Agent or Disinfector ........................................................................... 7—2
7.3.2 Manual Cleaning .............................................................................................................. 7—2
7.3.3 Advanced Sterilizing ........................................................................................................ 7—3
7.4 Breathing System Components .......................................................................................... 7—3
7.5 Bellows Assembly................................................................................................................ 7—3
7.5.1 Disassembling Bellows .................................................................................................... 7—4
7.5.2 Cleaning and Sterilizing ................................................................................................... 7—6
7.5.3 Regular Maintenance ...................................................................................................... 7—7
8 User Maintenance ..................................................................................................................... 8—1
8.1 Repair Policy ....................................................................................................................... 8—1
8.2 Maintaining Outline and Schedule ...................................................................................... 8—2
8.2.1 User maintenance ........................................................................................................... 8—2
8.2.2 Permissive Repairing....................................................................................................... 8—2
8.2.3 Useful life estimation ....................................................................................................... 8—3
8.3 Maintaining the Breathing System ...................................................................................... 8—3
8.3.1 Replace O2 sensor .......................................................................................................... 8—3
8.3.2 Calibrate O2 sensor ......................................................................................................... 8—3
8.4 Maintaining O2 sensor ......................................................................................................... 8—7
8.4.1 Technical requirements.................................................................................................... 8—7

iv
Contents

8.4.2 Recommended O2 sensor ............................................................................................... 8—7


8.5 Replace the fuses ................................................................................................................ 8—8
8.6 Maintaining battery .............................................................................................................. 8—9
9 Alarm and Troubleshooting ..................................................................................................... 9—1
9.1 About Alarm ......................................................................................................................... 9—1
9.2 Alarm message list .............................................................................................................. 9—2
9.2.1 Technical Alarm ............................................................................................................... 9—2
9.2.2 Functional Alarm .............................................................................................................. 9—5
9.3 Troubleshooting ................................................................................................................... 9—9
10.1 Schematic diagram ............................................................................................................ 10—1
10.2 System technical specification .......................................................................................... 10—2
10.2.1 Flow ........................................................................................................................... 10—2
10.2.2 Classification .............................................................................................................. 10—2
10.3 Input/Output ....................................................................................................................... 10—3
10.3.1 Electrical .................................................................................................................... 10—3
10.3.2 Pneumatic .................................................................................................................. 10—3
10.4 Electromagnetic Compatibility ........................................................................................... 10—4
10.5 Physical specification ........................................................................................................ 10—9
10.6 Environment Requirements ............................................................................................... 10—9
10.7 Breathing System technical specification ........................................................................ 10—10
10.8 Anesthetic Ventilator Specifications ................................................................................ 10—11
10.8.1 Electrical Schematic Diagram .................................................................................. 10—11
10.8.2 Ventilator performance............................................................................................. 10—12
10.8.3 Ventilation Mode Settings ........................................................................................ 10—12
10.8.4 Ventilating parameters settings ............................................................................... 10—13
10.8.5 Gas dynamics performance ..................................................................................... 10—13
10.8.6 Setting alarm parameters ........................................................................................ 10—14
10.8.7 Monitoring Performance .......................................................................................... 10—15
10.9 O2 Monitoring Specification ............................................................................................. 10—16
10.10 Latex Use .................................................................................................................... 10—16

v
1 Introduction
1.1 Intended Use
The ADSIII Anesthesia machine is intended for general anesthesia use. The ADSIII Anesthesia
machine will delivery operator set concentrations of oxygen and anesthesia gases as well as
deliver controlled breaths to the patient with either a constant or a deceleration flow pattern. ADSIII
Anesthesia machine is also intended to allow for the provision of manual ventilation.
Intended operator:
The ADSIII Anesthesia machine is intended for use by Healthcare professionals who are trained in
the administration of anesthesia.
Intended Patient Populations:
The Anesthesia machine is intended for use on the neonatal to adult patient populations in all
ventilation modes.
Intended Use Environment:
The Anesthesia machine is intended to be used in the environments where anesthesia is to be
administered by Healthcare professionals trained in administering anesthesia.
It is not intended for transport use in ambulances or helicopters.

WARNING: The user of ADSIII must be professional and trained.

WARNING: ADSIII is unsuitable for use in a MRI environment.

1.1.1 Range of use


ADSIII is applicable for patients, including adult and children, whose tidal volume is between 20ml
and 1400ml. ADSIII is mainly used in the Operating Room of hospital, and also used in Emergency
Room, Drug Addiction Treatment Center etc. where needs anesthesia.

WARNING: ADSIII is not to be used with infant.

1.1.2 Contraindication
ADSIII is not to be used with patients who have pneumothorax.

1—1
User Manual

1.2 Symbols

Warnings and Cautions indicate all the possible dangers in case of violation of the
stipulations in this manual. Refer to and follow them.
WARNING indicates potential hazards to operators or patients
CAUTION indicates potential damage to equipment
Instead of illustrations, other symbols may also be utilized. Not all of them may necessarily appear
in the equipment and manual. The symbols include:

AC: Alternating current Type B Applied Part

Attention, consult
DC: Direct current
accompanying document

Protective earth Dangerous Voltage

Equipotentiality Rotation in two directions

Movement in one direction Movement in two directions

Right-turning movement Left-turning movement from


from a limit a limit

Lock Unlock

Inspiration flow Expiration flow

SN Serial Number O2+ O2 flush

Bag operate / Manual Do not discard at garbage


ventilation bin

View the reading on the top


Fuse
of float

1—2
1. Introduction

Recyclable Battery

Variability, rotational
Bell cancel adjustment (increase
counter-clockwise)

Non-ionizing
Bell
electromagnetic radiation

Alarm, general Date of manufacture

Urgent alarm Address of manufacture

This device complies with


the requirements of
CE Representative
Medical Device Directive,
93/42/EEC.

1.3 Definition, abbreviation


AC141 Code name of Breathing System
AGSS Anesthetic gas scavenging transfer & receiving system
APL Adjustable Pressure Limit
BDU Basic Data Unit
C Compliance
CGO Common Gas Outlet
cmH2O Centimeters of Water
EEPROM Electrically Erasable Programmable Read Only Memory
FiO2 Fraction of inspired oxygen
Flow-t Flow-time waveform
Freq Frequency
FreqMIN Minimum Frequency in PS mode
I:E Inspiratory to Expiratory Ratio
IPPV Intermittent positive pressure ventilation
L Liter
L/min Liters per minute
Manual Manual ventilation
mL Milli Liter

1—3
User Manual

MRI Magnetic resonance imaging


MV Minute Volume
Paw Airway Pressure
Ppeak Peak pressure
Pplat Plat pressure
Paw-t Pressure-time waveform
PCV Pressure Control Ventilation
PEEP Positive End Expiratory Pressure
PIP Peak Inspiratory Pressure
PS Pressure Support Ventilation
PTARGET Target Pressure
SIMV Synchronized Intermittent Mandatory Ventilation
TINSP Inspiratory Time
TP Inspiratory Pause Time
Trigger Flow Trigger
TSLOPE Inspiratory Slope Time
UI User Interface
VT Tidal Volume
WDT Watch Dog Timer
ΔP Differential Pressure

1—4
2 System Components
2.1 Anesthetic System

WARNING: The anesthetic system is intended to be used with CO2 monitor in


accordance with ISO21647. Refer to section 5.3 about detailed
information that how to connect it.
WARNING: To avoid explosion hazards, flammable anesthetic agents such as ether
and cyclopropane shall not be used in this anesthetic workstation. Only
anesthetic agents which comply with the requirements for
non-flammable anesthetic agents as specified in this manual.
Halothane, desflurane, sevoflurane, enflurane, and isoflurane have been
found to be non-flammable agents.
WARNING: Independent means of ventilation (e.g. a self-inflating manually powered
resuscitator with mask) should be available whenever the anesthetic
system is in use.
WARNING: Do not use antistatic or electrically-conductive breathing tubes and
mask.
WARNING: Leakage and douse of liquid, such as anesthetic agent, bring on
dangerous states or malfunctions inside device.

2—1
User Manual

2.2 Front View

Figure 2-1 Front View


1 UI 2 Aux. flow meter knob
3 Aux. flow meter 4 Aux. O2 outlet
5 Aux. gas assembly 6 Bellows assembly
7 Absorber canister 8 Absorber canister mount release
9 AGSS 10 Castor(with brake)
11 Drawers assembly 12 O2 flush button
13 Push-and-pull handle 14 Pipeline gauges
15 Power switch 16 Cylinder gauges(optional)
17 Vaoprizers 18 Flow meter
19 Toplight switch

2—2
2. System Components

Item Diagram Description

Connects to other device which needs


Aux. gas
3 O2 supply, and the output pressure is
assy
40.5~87psi (280kPa~600kPa).

Press O2 Flush button to supply O2 to


5 O2 flush
the breathing system at high flow rate.

Castor (with Push down to lock, and pull up to


7
break) unlock.

Turn on the toplight switch,the toplight


Toplight
8 become illuminated. The toplight
Switch
switch can be set on low,high,and off.

Turn the knob counterclockwise to


increase the flow; turn clockwise to
decrease the flow.
10 Flow control
Read top of float when the flowmeter
is being read.

Turn on the switch, the unit will power


Power up, vice versa;
15
switch The switch doesn’t affect aux. mains
output and battery charge function.

2—3
User Manual

2.3 Rear View

Figure 2-2 Rear View


1 Hook 2 Aux. mains outlet
3 Power cable 4 Castor (without break)
5 AGSS tube 6 Drive gas hose
7 Breathing System Pneumatic Hose 8 Arm for UI
9 Gas inlet

Gas inlet module:

Figure 2-3 Figure 2-4


Figure 2-3 applys to European Standard and Figure 2-4 applys to American Standard

2—4
2. System Components

2.4 Breathing System

CAUTION: The breathing system used together with the anesthetic gas supply
system shall be in accordance with ISO 8835-2.

Figure 2-5 Breathing System


1 Absorber canister mount release 2 Absorber canister
3 Inspiratory port 4 Expiratory port
5 Expiratory valve 6 Bag Arm
7 Airway pressure gauge 8 Bellows
9 O2 sensor 10 Inspiratory valve
11 O2 sensor plug 12 APL valve

2—5
User Manual

Figure 2-6 Breathing System Bottom View

1 Heater inlet 2 Fresh gas inlet


3 Driving gas inlet 4 EVAC port
Figure 2 the breathing system components function control
Item Description
Absorber Two soda lime canisters are applied with a volume of 1500 ml for each so
1 canister mount that it can be continuously used for 6-8 hours at full load. The water from the
release reaction is drained via the water collector underneath.
Adjust the pressure limit of the breathing system during the manual
ventilation process. The readings are approximate. SP mark indicates that
9 APL valve
Breathing System operates as spontaneous ventilation during manual
mode.

2.5 Vaporizer

CAUTION: The Vaporizer used with the anesthetic system shall comply with ISO
8835-4.
Two vaporizers with Selectatec interface can be installed in this system, but only one vaporizer
can be opened at one time.

More detailed information about vaporizer, please refer to the instruction for use of the vaporizer
used in this anesthetic system.

2—6
3 UI
CAUTION: Anesthetic ventilator used in anesthetic system shall comply with ISO
8835-5.

CAUTION: Monitoring conditions of this system: Ambient temperature: 25°C; Air


temperature: 25°C; Air humidity: 30%; Gas component: O2.

3.1 Front Panel


Front panel consists of display screen, keys, indicators, and a knob. SeeFigure 3-1

Figure 3-1 Front Panel

3—1
User Manual

3.1.1 Keys
As the system is under STANDBY mode, press
AUTO/MANUAL key to shift to MANUALmode,
or turn the navigation knob to change to
MANUAL mode; the system will shift to IPPV
Manual/Auto Key mode by pressing AUTO/MANUAL key again.
Under other ventilation modes, press
AUTO/MANUAL key to shift to MANUAL mode,
press the key again to return to the previous
ventilation mode.

Press the key, open Alarm window on the


Alarm limits Key
screen; Press again, close the Alarm window.

Press the key, alarm mutes for 120 seconds.


MUTE Key
Subsequent alarms shall override the mute.

This key shall toggle the display between the


waveform window and the two loop display
configurations of the Spirometry Loop Window
described in section 4.5. The first key press
shall display the “Pressure-Volume” loop
Spirometry Key display configuration. The second key press
shall display the “Flow-Volume” loop display
configuration. After both configurations have
been cycled through the display, a third key
press shall return the display to the Normal
Screen.
Press the key, a “Menu” window appeared on
the display screen, more details refer to section
3.4.
MENU Key
The first menu key press after initial power up
shall bring up the Calibrate menu with Start
Calibration highlighted.
A key that shall close the “Menu”, “Spirometry”
and “Alarm” windows and return screen to
pressure and flow waveforms.
Normal screen Key If the “Menu”, “Spirometry” and “Alarm”
windows are already closed when the NORMAL
SCREEN key is pressed again, no action shall
occur.

3.1.2 Indicator

AC indicator The indicator brightly as AC power effectively;


The indicator dark as AC power failure.

3.1.3 Navigator knob


The user may use the rotary knob to select the menu item and modify the setup. It can be rotated
clockwise or counter-clockwise and pressed like other buttons. The user may use the knob to
realize the operations on the screen and in the system menu and parameter menu.
The rectangular mark on the screen that moves with the rotation of the knob is called “cursor”.
Operation can be performed at any position at which the cursor can stay.

3—2
3. UI

Operating method:
 Move the cursor to the item where the operation is wanted

 Press the knob

 One of the following four situations may appear:


 The background color of cursor may become into the contrast color, which implies
that the content in the frame can change with the rotation of the knob.

 Pull down menu or dialogue box may appear on the screen, or the original menu is
replaced by the new menu.

 Save setup.

3.2 Screen Layout


The display of the ventilator is a color TFT, which can display the monitoring and setting
parameters, waveforms, alarm information as well as displayed on the screen. See Figure 3-2.
The screen has three areas: information area, monitoring area, and parameter setup area.

Figure 3-2 Display screen layout

3—3
User Manual

3.2.1 Information Area


The information area is divided into seven areas: Alarm Indication, Alarm Messages, Date, Time,
Power Source, Patient Type and Ventilation Mode.

3.2.1.1 Alarm Indication

The bell icon shall be displayed when an alarm is present. When it appears, the color of alarm bell
shall be white. Pressing the alarm mute key shall place an “X” dashed line on the alarm bell for
120 seconds. Displayed below the bell icon shall be a countdown timer which shall display
remaining silence time.

3.2.1.2 Alarm Messages

Technical Alarm and Functional Alarm shall be displayed in the alarm message area. High Priority
alarms shall be colored red. Mid and low priority alarms shall be colored yellow. Up to 2 alarm
messages shall be displayed on the screen. More details refer to Chapter 9.

3.2.1.3 Date

The display mode of Date has three types: MM/DD/YY, DD/MM/YY or YY/MM/DD.

3.2.1.4 Time

The display mode of Time has 2 types: 12 hour or 24 hour format.

3.2.1.5 Power Source

Located the left of Ventilation Mode tile, there are two icons: AC and Battery.
The display status of Battery includes: Full, Charging and Capacity left.
The display status of AC includes: AC available/ready and AC failure.
AC power up: (1) The Battery icon shows 100% capacity as solid when fully charged. (2) if in
charging, the Battery icon shows animated capacity.
AC power down: (1) The Battery icon shows the current capacity. (2) The Battery can supply
power for the machine about 15 minutes when low battery alarm occurs.

3.2.1.6 Patient Type

The patient type shall be displayed as Adult or Child. Highlighting (black text on white background)
the Patient type tile and pressing the navigator knob shall toggle the patient type between Adult
and Child. Changing patient type shall be possible in standby mode only.
The default patient type on power-up shall be ADULT.

3.2.1.7 Ventilation Mode

Pressing the navigator knob when the Mode tile is highlighted shall display the current ventilation
mode in white text on a black background and the “MODE” label shall remain displayed in black
text on white background. Rotating the navigator knob clockwise shall allow the user to scroll
through the ventilation mode selections; STANDBY, IPPV, PCV, SIMV and PS. Rotating the
navigator knob counterclockwise shall scroll through the settings in the reverse order.
STANDBY shall be the default mode on initial power up.

3—4
3. UI

3.2.2 Monitoring Area


Monitoring area has two parts: Patient waveform and parameters. See Figure 3-2.

3.2.3 Parameters Setup Area


The parameter setup area shall contain 8 tiles of fixed vertical height, and fixed horizontal width
and each tile shall contain the tile’s parameter value. Each tile represents a location that may be
highlighted by the navigator knob. Current parameter settings shall be displayed in reverse video
in the parameter window when a parameter tile is highlighted (black text on white background).
Rotating the navigator knob clockwise shall allow the user to increase the setting and rotating
counterclockwise shall decrease the setting. When the selection reaches its maximum or minimum
setting, further rotation shall result in the minimum or maximum setting being displayed. Pressing
the navigator knob selects the parameter setting and it shall be displayed as white text within a
black field. Parameter settings shall be in normal video unless the parameter tile has been
selected or highlighted. Parameter tiles shall be populated as per the table 3-1 below.
A timeout shall occur when a parameter tile is selected or changed but not confirmed for 15
seconds. Upon a timeout, the parameter setting shall revert back to the previously confirmed
value.
The parameter timeout shall be available for the following items:
 Ventilation Mode.
 Patient Type
 All ventilation parameter settings.
Vent Paramet Paramet Paramet Paramet Paramet Paramet Paramet Paramet
Mode er Setup er Setup er Setup er Setup er Setup er Setup er Setup er Setup
1 2 3 4 5 6 7 8
Stand
Blank Blank Blank Blank Blank Blank Blank Blank
by
IPPV VT Freq I:E TP PEEP Blank Blank Blank
PCV PTARGET Freq I:E Blank PEEP Blank Blank TSLOPE
SIMV VT Freq TINSP TP PEEP ∆P Trigger TSLOPE
PS Blank FreqMIN Blank Blank PEEP ∆P Trigger TSLOPE
Manua
Blank Blank Blank Blank Blank Blank Blank Blank
l
Table 3-1

3—5
User Manual

3.3 Rear Panel

Figure 3-3 Rera Panel


COM A interface Communication interface A. RS232 compatible.
COM B interface Communication interface B. RS232 compatible.
SIGNAL interface Signal interface, used for connecting display screen to main unit. I/O
signal interlinkage between UI and main unit.

3—6
3. UI

3.4 Menu
3.4.1 Operating Guide
Calibrate or carry out other process, explanation will be displayed on the screen.

3.4.1.1 Alarm Setting

The following figures display each submenu in the Menu window.


Press MENU key, the Menu window will display on the screen.

Turn the knob to select a submenu.

Step 1
Press MENU key, then display a “Menu” window on the screen.
The following example is given to illustrate how to operate the detailed settings.

Figure 3-4 Alarm setting


Step 2
Turn the knob to select Paw-High option, and then this option background as shown in black text
on white background.

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User Manual

Figure 3-5 Alarm setting


Step 3
Press the knob, and then enter the option selected which shows in white text on black background
and the option selected can be adjusted.

Figure 3-6 Alarm setting


Step 4
Press the knob to save the changed result. Also, the option adjusted restores black text on white
background.

3—8
3. UI

Figure 3-7 Alarm setting

NOTE: The parameter settings for MV, Freq., FiO2 and Alarm Volume are the same as
the method for PAW setting.

3—9
User Manual

3.4.1.2 System Setting

Step 1
There are two forms for PRESSURE DISPLAY: Plat and Pmean.Press the knob to select the
target pressure display form.

Figure 3-8 Pressure display setting

Figure 3-8 Pressure display setting


Step 2
There are two forms for LANGUAGE: Chinese and English.Press the knob to select the target
language.

3—10
3. UI

Figure 3-9 Language setting

Figure 3-10 Language setting


Step 3
There are two forms for DISPLAY: live and demo.Press the knob to select the display form.

3—11
User Manual

Figure 3-11 Display setting

Figure 3-12 Display setting


Step 4
Press the knob to select the DATE option.

3—12
3. UI

Figure 3-13 Date setting


Press the knob as the SET FORMAT is white font under black background,turn the knob to select
the format wanted and press the knob again to select it.

Figure 3-13 Date setting


Press the knob as the ADJUST DATE is white font under black background; turn the knob to select
the date and press the knob again to select it.

3—13
User Manual

Figure 3-14 Date setting


Then select DONE to confirm the date.

Figure 3-15 Date setting


Step 5
Press the knob to select the TIME option.

3—14
3. UI

Figure 3-16 Time setting


Press the knob as the SET FORMAT is white font under black background; turn the knob to select
the time format and press the knob again to select it.

Figure 3-17 Time setting


Press the knob as the ADJUST DATE is white font under black background; turn the knob to select
the time and press the knob again to select it.

3—15
User Manual

Figure 3-18 Time setting


Select DONE to finish time setting.

Figure 3-19 Time setting


Step 6
Press the knob to select RESTORE DEFAULTS option.

3—16
3. UI

Figure 3-20 Restore defaults setting


Select DONE to make settings restore to their defaults.

Figure 3-21 Restore defaults setting


Select CANCEL to retain parameters at their current settings.

3—17
User Manual

Figure 3-22 Restore defaults setting


Step 7
Press the knob to select LEAK TEST option.

Figure 3-23 Leak test setting


Press the knob again and the leak test results will show on the screen.Select DONE to exit.

3—18
3. UI

Figure 3-24 Leak test setting

3—19
4 Operating Guide
4.1 Startup
Step 1 Connect Mains Supply
Plug the power cord into AC power outlet, The AC indicator on the UI will be bright.
Step 2 Turn on Power Switch
Turn the Power Switch to “ON”, the UI shall be powered on and perform System Self Test.

4.1.1 System Selftest

NOTES: The color of a hand icon is white, which is in consistent with the color of
the operating procedure being performed.

NOTES: If system leak test fails, the mechanical ventilation modes, such as IPPV,
SIMV, PCV and PS will be retained.

NOTES: As CO2 waveform setting will be saved, the default status is the one that
is setup in the previous operation.

The display enters startup interface when UI powered on, and then the LOGO interface will be
shown as follows, See Figure 4-1.

Figure 4-1 Logo interface


The System Self test interface will appear after LOGO interface finished, see Figure 4-2.

4—1
User Manual

Figure 4-2 System Self Test interface


The System Self Test Complete interface, as following picture, will appear if self test finished.

Figure 4-3 System Self Test Complete interface


Select Continue option in the above figure to perform Leak Test procedure, Select Bypass to enter
Standby interface directly, see Figure 4-14.
If selftest failure, please contact service representative.

4—2
4. Operating Guide

4.1.2 Manual Leak Test


The Leak Test includes Safety valve test, verification of APL valve and Flowmeter. Click Continue
option in Figure 4-3 to start to perform the leak test, see the figure as follows:

Figure 4-4 Setup before Manual Leak Test


Perform the following operation according to the prompts in the above figure.

Figure 4-5 Manual Leak Test

4—3
User Manual

4.1.3 Safety Valve Test


Click the Continue option in Figure 4-5 to perform Safety valve test as shown in the following:

Figure 4-6 Safety valve Test in progress


The following figure will be shown on the display screen when safety valve test completed.

Figure 4-7 Safety valve Test Pass interface

4—4
4. Operating Guide

4.1.4 Automatic Leak Test


The following interface appears on the screen after safety valve test completed.

Figure 4-8 Automatic Leak Test


Click Continue option to perform Leak Test.

Figure 4-9 Automatic Leak Test in progress

4—5
User Manual

The following interface appears after automatic leak test completed.

Figure 4-10 Automatic Leak Test Pass interface


Select Continue option in the above figure to perform the next step operation, select Retry to
perform the automatic leak test again.

4—6
4. Operating Guide

4.1.5 Compliance Test

Figure 4-11 Compliance Test in progress


Click Continue option in Figure 4-10 to perform Compliance test, see the following figure:

Figure 4-12 Compliance Test in progress


The following interface will appear on the screen after compliance test completed.

4—7
User Manual

Figure 4-13 Compliance Test complete interface


Click Continue option, the Standby interface appear on the screen as follows:

Figure 4-14 Standby interface

4—8
4. Operating Guide

4.1.6 Ventilation Mode Setup


Current ventilation mode shown at top right
corner of the display, with arrow pointed up.
Standby mode
IPPV mode
PCV mode
SIMV mode
PS mode
Manual mode

Step 1
Turn the knob; make cursor point to the current ventilation mode.

CAUTION Exit the menu before carrying out this step.

Step 2
Press the knob to make sure the grounding changed.
Step 3
Turn the knob to select ventilation mode required.
Step 4
Press the knob to save the setup.

4.1.7 Breathing Parameters Setup


The setting method refers to section 4.1.6.

4—9
User Manual

4.2 Start Mechanical Ventilation

WARNING: Before getting started, make sure to set the patient circuit installing and
controlling correctly.
The following procedures assume that the system is in on position and
manual reservoir gas ventilating mode.
WARNING: Before getting started, make sure to set the patient circuit installing and
controlling correctly.
NOTES: As the system is under STANDBY mode, press AUTO/MANUAL key to
shift to MANUALmode, or turn the navigation knob to change to
MANUAL mode; the system will shift to IPPV mode by pressing
AUTO/MANUAL key again. Under other ventilation modes, press
AUTO/MANUAL key to shift to MANUAL mode, press the key again to
return to the previous ventilation mode.

Step 1
Make sure the control settings coincide with the clinical settings, and check that the current alarm
preset is appropriate prior to use on each patient.

Step 2
Select auto ventilation. Setting steps refer to section 4.1.6.

Step 3
If necessary, push the O2 flush button to inflate the bellows.

4.2.1 Stop Mechanical Ventilation


Set ventilation mode to Manual or Standby mode.

4—10
4. Operating Guide

4.3 Start Manual Ventilation

Step 1
Before stopping the auto ventilation, make sure the setting of manual circuit is complete, and the
setting of APL valve is correct.
APL valve is used to adjust the pressure limit of the breathing system during the manual ventilation
period.
Step 2

Set ventilation mode to Manual mode, or press key directly. So you can use the
resovior bag to perform manual ventilation, if necessary, push the O2 flush button to inflate the
bellows.

4.3.1 Stop Manual Ventilation


Set Ventilation Mode to Standby mode.

4.4 Shutdown
Turn off gas supply firstly, then set ventilation mode to Standy mode after the gas within the
system exhausted.

4—11
User Manual

4.5 Waveforms
4.5.1 Paw-t waveform
Y-Axis: airway pressure; X-Axis: time. More details refer to section 10.8.7.

Figure 4-15 Paw-t waveform

4.5.2 Flow-t waveform


Flow scale: -90 to 90L/min. Time scale: 0 to 15s.
Time-Axis: Positive inspiratory direction above 0L/min level; minus expiratory direction
below 0L/min level; no gas flow on 0L/min level.

Figure 4-16 Flow-waveform

4—12
4. Operating Guide

4.5.3 Pressure-Volume Loop


Y-Axis: pressure; X-Axis: tidal volume. See Figure 4-17.

Figure 4-17 Pressure-Volume Loop

4.5.4 Flow-volume Loop


Y-Axis: flow; inspiratory flow above 0L/min level; expiratory flow below 0L/min level.
X-Axis: tidal volume. See Figure 4-18.

Figure 4-18 Flow-volume Loop

4—13
5 Preuse Checkout
5.1 Preuse Checkout Procedure
Test interval Preoperative Checkout should be done in the following situation:
Before use of the first patient each day.
Before use of each patient.
After repair or maintenance.
Test schedule is given in the table below:
Before use of the first patient each day Before use of each patient
System check: Breathing System test:
Power failure alarm test: Ventilator test:
Gas pipeline and gas cylinder test:
Flow control test:
Vaporizer installation and test
Alarm test:
Breathing system test:
Ventilator test:

WARNING: Do not use this system before the operation and maintenance manual
are read and understood.

 Whole system connection

 All warnings and cautions

 Using guide of each system module

 Testing method of each system module

Before using this system:

 Complete all tests of this section


 Test all the rest of system modules
If test failure, do not use this system. Please contact service representative.

5—1
User Manual

5.1.1 Check System

WARNING: make sure the breathing circuit is connected correctly and in good
condition.

Make sure:
1 Equipment is in good condition.

2 All the components are correctly connected.


3 Breathing circuit is correctly connected and in good condition; there is sufficient
absorbent in the breathing system.

4 Vaporizer is in lock position and is filled with sufficient anesthetic.

5 The connection and pressure of pipeline gas supply system are correct.
6 The connected cylinder valve should be closed if there are backup cylinders.

7. The required emergency device is ready and in good condition.

8. The device for airway maintenance, organ cannula are ready and in good condition.

9. The applicable anesthetic and emergency medicine are ready.

10. Make sure the truckles are tight and locked and free of motion.
11. Connect the power cord to the AC power outlet. The power indicator light will light up
when power is connected.

If failure, that means no electric power supplying. Exchange other sockets, close breaker,
or replace power cord.

5.1.2 Power failure alarm test


1 Turn the Power Switch to ON position.

2 After operating 5 minutes, pull out power cord.


3 Make sure that power off failure alarm occurs, it has the following characteristics:
a) Alarm sound;
b) “Power Failure!” message displays on the screen;
c) Mains icon flickering.

4 Connect power cord again.

5 Make sure the alarm eliminate.

5—2
5. Preuse Checkout

5.2 Test gas supply pipeline and cylinder

CAUTION: A user must confirm that gas supply is connected correctly; there is no
any disconnection, leakage, faulty connection in gas circuits and
pressure indicates correctly. Stop using and check gas connections if
abnormal.

CAUTION: To prevent from damage:


Open cylinder valve slowly.
Never control the flow with excessive force.
Skip step 2 if the system is not using cylinder gas supply.
1 Disconnect all pipeline gas supply and close all the cylinder valves.
 If the readings of the pipeline pressure gauge and cylinder pressure gauge are not
zero.
 Switch on O2 supply.
 Adjust flow control to middle range.

 Make sure all the pressure gauges are reset to zero except the O2 pressure gauge.
 Switch off O2 supply.
 Make sure the O2 pressure gauge is reset to zero. The low O2 supply alarm should
be on when pressure drops.

2 Make sure cylinders are fully filled:

 Open each cylinder valve.


 Make sure the pressure of each cylinder is high enough. In case the pressure is
insufficient, close the corresponding cylinder valve and install a fully filled cylinder.

3 Test cylinder high pressure leak one by one.

4 Close flowmeters.

5 Open the cylinders.


6 Record the cylinder pressures.

7 Close the cylinder valves.

8 Begin to record the pressures after one minute. If O2 pressure drops to 5000kPa, it
means there is a leakage:
 If leakage exists, according to direction of section 5.5, replace a new sheet gasket,
and then tighten T handle.

 Perform this step again. If leakage exists all the same, do not use this system.

9 Step 5 ~ 7 should be repeated for all the cylinders. N2O pressure drop in one minute
should not exceed 700kPa.

10 Close all the cylinder valves.

5—3
User Manual

CAUTION: Do not leave the cylinder valves open during pipeline gas supply period;
otherwise, cylinder gas supply will be used up and lead to insufficient
supply in case of pipeline malfunction.

11 Connect pipeline gas supply.

12 Check pipeline pressure according to the table below:

ANSI (U.S. and International), Australia, Canada, 345kPa (50psig)


France and Japan
ISO, Italy, Scandinavia, South Africa, Spain and Switzerland 414kPa (60psig)
Austria and Germany 500kPa (75psig)

5.3 Monitoring Flow Control

WARNING: Refer to Step 1 to 13 of monitoring without oxygen for monitoring


without oxygen.
Refer to Step 1 to 13 of monitoring with oxygen for monitoring with
oxygen.

5.3.1 Monitoring without oxygen

WARNING: The monitoring system cannot be replaced by link system. The fresh
gas containing enough oxygen may not avoid the existence of low
oxygen mixture in the breathing circuit.

WARNING: If N2O exists, it will pass through the system during the test, which
should be securely collected and removed.

WARNING: Patients may be injured by improper gas mixture. The link system
should not be used if a proper ratio of O2 and N2O is not possible.

WARNING: The following procedures can test whether the link system has serious
malfunction; however, it cannot determine whether the calibration is
correct.

CAUTION: The gas flow control valve should be adjusted slowly. Do not turn it
hard when the reading of the flowmeter goes beyond the maximum or
minimum flow rate; otherwise, the control valve can be damaged and
the control will not work.

5—4
5. Preuse Checkout

Follow the steps to test the flow control:


1. Connect the pipeline gas supply or open the cylinder valves slowly.

2. Turn clockwise all the flow control till the end.

3. Turn on mains switch.


4. Do not use this system if the battery is not fully charged or other ventilator failure alarm occurs.
5. Make sure:

 No gas flowing in any flow tube.

 Step 6 and step 7 are only applicable for the N2O system test.

WARNING: During Step 6 to Step 7, keep link systems working state.


Only adjust testing of control (N2O in step 6 and O2 in step 7).
Adjust flow according to order (N2O firstly O2 secondly).
If adjustable range exceeds, please adjust flow control to the nearest
place and perform this step again.

6. To test the flow increase of the link system:

 Turn clockwise the N2O and O2 flow control till the end.

 Turn counterclockwise the N2O flow control slowly.


 Set N2O flow control to the rate described in the following table. The O2 flow must be
higher than the minimum flow limit.

Set N2O flow to O2 flow must be higher than the minimum flow
(liters per minute): (liters per minute):
1.5 0.5
3 1
6 2
9 3

5—5
User Manual

7. This step tests the function of the Link System when flow is reduced, you should:

Set N2O flow to O2 flow must be higher than the minimum flow
(liters per minute): (liters per minute):
6.0 2.0
3.0 1.0
0.6 0.2

8. Adjust full flow of all the gas to ensure that the flowmeter float must move smoothly.

9. Shut off the oxygen supply either by closing the oxygen cylinder valve, or by disconnecting
the oxygen pipeline supply.
10. Make sure:

 As pressure decreases, the oxygen-supply failure alarm must continuously sound.

 Disconnect the flow of nitrous oxide and oxygen to be sure that the oxygen flow will be
the last to stop.
 Air flow remains.
 If the oxygen is the driving gas of the ventilator, the oxygen-supply failure alarm must
continuously sound.

11. Turn all flow control valves completely clockwise to the close.

12. Reconnect O2 pipeline supplies or slowly open the O2 cylinder valve.


13. Turn off mains supply.

5—6
5. Preuse Checkout

5.3.2 Monitoring with Oxygen

WARNING: The monitoring system cannot be replaced by link system. The fresh
gas containing enough oxygen may not avoid the existence of low
oxygen mixture in the breathing circuit.

If N2O exists, it will pass through the system during the test, which
should be securely collected and removed according to safe and
eligible methods.
Patients may be injured by improper gas mixture. The link system
should not be used if a proper ratio of O2 and N2O is not possible.

CAUTION: Before continuous testing, perform test of the O2 monitoring device


according to step 8 in section 4.6.
Follow the steps to test the flow control:

1. Connect the pipeline gas supplies, or slowly open the cylinder valve.

2. Turn all flow control valves completely clockwise to the close.

3. Turn on mains switch.

4. Do not use this system if the battery is not fully charged or other ventilator failure alarms occur.

5. Make sure:

 No gas flowing in any flow tube.

 Step 6 and step 7 are only applicable for the N2O system test.

WARNING: During Step 6 to Step 7, keep link systems working state.


Only adjust testing of control (N2O in step 6 and O2 in step 7).
Adjust flow according to order (N2O firstly O2 secondly).
The oxygen sensor being used must be calibrated correctly.

6 To test the flow increase of the link system:

 Turn clockwise the N2O and O2 flow control till the end.
 Turn counterclockwise the N2O flow control slowly.

 Make sure that the O2 flow is increasing. The concentration of the oxygen tested must ≥
25% during the complete process.

5—7
User Manual

7 To test the flow increase of the link system:

 Set the N2O flow to 9L/min.


 Set the O2 flow to 3L/min or higher.

 Turn the O2 flow control valve clockwise slowly.


 Be sure that the O2 flow is getting reduced. The FiO2 tested must ≥ 25% during the
complete process.

8 Adjust all of the gas full flow to ensure that the flowmeter floats must move smoothly.

9 Shut off the O2 supply either by closing the O2 cylinder valve, or by disconnecting the O2
pipeline supply.

10 Make sure:

 As pressure decreases, the oxygen-supply failure alarm must continuously sound.

 Disconnect the flow of nitrous oxide and oxygen to be sure that the oxygen flow will be
the last to stop.

 Air flow remains.


 If oxygen is the driving gas of the ventilator, the oxygen-supply failure alarm must
continuously sound.

11 Turn all flow control valves completely clockwise to the close.

12 Reconnect O2 pipeline supplies or open the O2 cylinder valve slowly.

13 Turn off mains supply.

5—8
5. Preuse Checkout

5.4 Installing andTesting of Vaporizer


5.4.1 Installation

WARNING: Do not take the vaporizer away from the bypass valve with its locking
lever locked.
Do not use more than one vaporizer at the same time in this system.
Install vaporizers in accordance with the following steps:
1. The vaporizer must be disassembled and reinstalled if its top is not horizontal.
2. Set the locking lever of the vaporizer so that it is locked.

3. Try to lift the vaporizer directly upwards so as to separate itself from the bypass valve, but do
not pull the vaporizer forwards. Be careful not to rotate it on the bypass valve.

4. As the vaporizer is taken away from the bypass valve, reinstall the vaporizer and then follow
step 1 to step 3. Do not use this system if you cannot put return the vaporizer to a horizontal
position on the bypass valve.

5. Try on opening two vaporizers at the same time.


 Testing any possible instance of each combination.

 If more than one vaporizer can be opened at the same time, disassemble and reinstall
them, then perform step 1 to step 5.

5.4.2 Testing Vaporizer

CAUTION: About performance testing of vaporizer refer to relevant instruction for


use.

5—9
User Manual

5.5 Alarm Test


1 Connect simulation lung to Patient end.

2 Turn on Power Switch.


3 Set control options:

Ventilation mode: IPPV mode


Ventilator: VT: 700ml
f: 20bpm
I:E: 1:2
Plimit: 40cmH2O
Anesthetic machine: All gas: close
Press O2+ button to inflate bellows.

4 Set ventilation mode to Manual ventilation, and then set to IPPV control again. Make sure:
 Auto ventilation start.

 Display right data on the screen.

 Bellows up and down during auto ventilation.

5 Adjust O2 flow to 5L/min.


6 Make sure:
 Pressure at the end of expiration is not more than 3cmH2O.
 Right data displayed on the screen.

 Bellows up and down during auto ventilation.


7 Test O2 monitoring and alarm:
 Remove O2 sensor from the absorber cycle, and confirm that O2 concentration measured
in the room air is about 21%.
 Adjust lower limit of O2 concentration to 50%, and confirm that “Low FiO2!!!” alarm
occurs.
 Adjust lower limit of O2 concentration to 21% again, and confirm that the alarm
eliminates.

 Put O2 sensor back to the AC110.


 Adjust upper limit of O2 concentration to 50% again.
 Press O2 flush to charge the breathing system, and confirm that “High FiO2!!” alarm
occurs.

 Adjust upper limit of O2 concentration to 100%, and conform that the alarm eliminates.
 Let O2 sensor pass pure O2 for 2 minutes, and conform that O2 concentration measured
is about 100%.

5—10
5. Preuse Checkout

8 Test low minute volume alarm:


 Turn to “Alarm” submenu.

 Adjust lower limit of MV to 16L/min, and conform that “Low Minute Volume!!” alarm
occurs.

 Turn to “Alarm” submenu again.


 Adjust lower limit of MV to 10L/min, and conform that the alarm eliminates.

9 Test high airway pressure alarm:

 View Ppeak on the screen.


 Adjust lower limit of Paw to below Ppeak, and conform that “High Airway Pressure!!!” alarm
occurs.
 Adjust lower limit of Paw to above Ppeak, and conform that “High Airway Pressure!!!” alarm
eliminates.

10 Test low airway pressure alarm:

 Remove reservoir bag form the absorber circle.


 Other alarm occurs, such as “Low Minute volume!!”.

 Make sure that “Low Airway Pressure!!” alarm occurs.

11 Test continuous high airway pressure alarm:

 Set control options:


 APL valve:  Set to the maximum value
 Ventilation mode:  Bag
 Set ventilation mode to Manual Mode, auto ventilation should stop.
 Block up patient end and press O2+ button.
 Make sure that “Continuous Pressure!!!” alarm occurs after 15 seconds approximately.

12 Turn off Power Switch.

5—11
User Manual

5.6 Breathing System Test


Verify the non-return valve in the Breathing circuit module works normally:
The non-return exhalation valve will ascend during the exhalation period while it will descend
during the inhalation period.

WARNING: Objects in the breathing system can interrupt or disrupt the delivery of
breathing system gas, resulting in possible patient death or injury:
Do not use any testing plug small enough to slip completely into the
breathing system.

5.6.1 Check O2+ Button


Press the O2+ button (the sound of gas should be heard from the fresh gas outlet) then release.
The button must immediately drop back to its position and stop delivering the gas.

5.6.2 Testing Breathing System


Set the ventilation mode to Manual Mode. The airway pressure gauge is zeroed. APL Valve should
be rotated fully clockwise to the maximum. Install the Breathing circuit.
Connect reservoir bag to the Bag Arm port of Breathing System. Press the O2+ button or open the
flowmeter to make the indication of the airway pressure gauge achieve 3kPa, then release the
button and close the flowmeter. After 20 seconds observation, the pressure drop indicated by the
airway pressure gauge must not exceed 0.3kPa.

5.6.3 APL Valve Test


Adjust the positions of every switch and knob according to the method of testing Breathing System
Leak. Open the O2 flow to 5L/min. Adjust the APL valve to position the pressure of the pressure
gauge in different places respectively. The common gas outlet must overflow some gas as the
pressure is stable.

WARNING: Be sure that there is no any testing plug or foreign objects in the
Breathing System.

5.7 Ventilator Test


1 Connect the simulation lung to the patient end.
2 Set the ventilation mode to the bag control.

3 Turn on Power Switch.


4 Set control options:

Ventilation mode: IPPV mode


Ventilator: VT: 700ml
f: 20bpm
I:E: 1:2
Plimit: 40cmH2O
Anesthetic machine: O2 flow: less than 200mL
All other gas: close

5—12
5. Preuse Checkout

5 Set the ventilation mode to IPPV Mode.


6 Press the O2+ button to inflate the bellows.
7 Ensure:

 Auto ventilation start.


 No low pressure alarm.
 Ventilator displays the correct data.
 The bellows ascend and descend during auto ventilation.
8 Set the O2 flow control to 5L/min.
9 Ensure:

 Ending expiratory pressure is not more than 3cmH2O.


 Ventilator displays the correct data.

 The bellows inflate and scavenge during auto ventilation.

10 Set the ventilator control and alarm limits to the proper clinical level.

11 Turn off mains supply and close all valves of gas cylinders if not to use the system.
12 Ensure that the things in the following table should be prepared completely.

Apparatus: Airway maintenance


Manual ventilation
Organ cannula
anesthesia and emergent drugs applicably

13 System preparation:

 Close all vaporizers.


 Open the APL valve.

 Set the bag / ventilator switch to bag control.

 Set all the flow controls to the minimum.

 Be sure that the breathing system connects correctly

WARNING: Be sure that the breathing system connects correctly.

WARNING: Flush the anesthesia machine for at least one minute by using O2 with
5L/min flow speed to remove unnecessary mixed gas and objects in the
system before connecting the equipment to the patient end.

WARNING: Anesthesia equipment must be connected to the waste gas scavenging


system to outlet the waste gas to prevent the staff working in the
operating rooms from injury.
This requirement must be followed in the testing and clinical
application.

5—13
6 Installation and Connection
CAUTION: O2 monitoring must be used on this equipment. For the related
stipulations, refer to local standards.

CAUTION: According to IEC 60601-2-13 / ISO 8835-1, this equipment must use
expiratory volume monitoring, O2 monitoring (in accordance with EN
12342 or ISO 21647) and CO2 monitoring (in accordance with EN 864 or
ISO 21647).

CAUTION: Anesthetic monitoring (in accordance with ISO 21647:2004) must be


made as the anesthetic vaporizer is being used according to the
European standard and International Standard IEC 60601-2-13 / ISO
8835-1.

WARNING: Operating room environment can be influenced by the expiratory gas.


Some unexpected dangers may occur if the anesthetic has been not
tested for a long time. The operator must dispose of expiratory gas in a
timely fashion according as required, and examine other items to
minimize the chances of danger and malfunction.

WARNING: Be sure the gas pipeline supply hoses and the breathing circuit
components are non-poisonous, do not cause patient allergy, and do
not create dangerous by-product through reaction with the anesthesia
gas or the anesthetic.

WARNING: To prevent generating wrong data and malfunction, please use the
cables, hoses, and tubes from our company.

CAUTION: It is dangerous if there is anesthetic in the absorber. Measures must be


made to prevent the soda lime in the absorber from drying. Turn off all
the gas supplies after finishing using the system.

CAUTION: This system can be operated correctly under IEC 60601-1-2 interference.
Higher-level interference may cause alarm and result in auto ventilation
suspension.

CAUTION: To avoid equipment false alarm caused by high strength electric field:
 Put the electricity surgical conducting wire far from the place where the
breathing system and the O2 sensor are put on.

 Do not put the electricity surgical conducting wire on any parts of the
anesthetic system.
CAUTION: To protect the patient, as the electricity surgical equipment is being
used:
 Monitor and ensure that all the life supporting and monitoring
equipment are operated correctly.

 Ensure that the backup manual ventilator can be used immediately in


case that electricity surgical equipment cannot secure the use of
ventilator.
 Never use electrical conduction masks or hoses.

6—1
User Manual

6.1 Installation

Step 1
Unpack the package, take out the main frame and lock its castors so it cannot move freely.

Step 2
Connect the arm to its mounting tracks, then
tighten the screws.

Step 3
When installing, hold the top plate of the
Breathing System with both hands, connect the
position fixing hole to the limb post, sit it on the
limb post.

6—2
6. Installation and Connection

6.2 Install Absorber Canister

WARNING: Follow the proper security measures:


 Do not use the absorber if the anesthetic is chloroform or trichloroethylene.
 Avoid to let the skin or eyes touch the materials in the absorber. Clean the affected part
immediately and seek medical attention if materials come in contact with skin or eyes. Do not
replace absorber during the period of ventilating.
 Do not replace the absorber if the Breathing System is in operation.
 Replace the absorbent often to prevent the deposition of non-metabolism gas as the system
is not on.
 Check the color of the absorbent after finishing each case. The original color of the absorbent
may be restored when not in use. Refer to the labels of the absorbent for the details.
 Carbon monoxide is released if completely dried absorbent contact with the anesthetic.
Replace the absorbent for security.
 Perform leakage testing of breathing system in Manual Mode mode after disassembling the
absorber.
The absorber in this system can be used repetitious.
The capacity of each absorber canister is 1500mL.
Only air, oxygen, carbon monoxide, halothane, enflurane, isoflurane, sevoflurane and can
desflurane be used for the absorber.

6.2.1 When to Replace Absorbent


Changed color of the soda lime in the absorbent indicates that it has absorbed the carbon dioxide;
however, this color is not 100% accurate. To decide whether to replace the absorbent, use CO2
monitoring machine.
Remove the changed-color absorbent immediately. The soda lime will restore its original color
several hours later and that may mislead the operator.

6.2.2 Disassembling Absorber


The absorber is reusable. Follow the disassembling procedures:
1 Turn on drain valve to get rid of water
generated by chemical reaction.

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User Manual

2 Rotate the handle anticlockwise to


disassemble the absorber.

Tip the absorber canister to remove it.

6.2.3 Filling Absorbent


1. Remove the absorbent of absorber.

2. Cleaning and sterilization refer to section 7.3.

3. Fill the absorber with fresh absorbent after dryness. Wipe soda lime fell on the edge of
absorber, and then install it back. Make sure the airtightness is well, and that no leakage
and spillage.

6—4
6. Installation and Connection

6.3 Connecting Tubes and Cables

CAUTION: CO2 monitor (in accordance with ISO 9918) should be connected at
L-piece of patient end.

CAUTION: Anesthetic machine should be used with anesthetic agent monitor.


Anesthetic agent monitor (e.g. Datex-ohmeda S/5 Anesthetic gas
monitor) should in accordance with ISO 21647:2004, and it should be
connected at T-piece installed inspiratory port.

CAUTION: O2 sensor should be connected at T-piece installed inspiratory port.

Step 1: Install the common gas outlet:


Connect the common gas outlet and the fresh
gas inlet with pipe, and then screw down the
cap to fix.

Step 2: Connect Driving gas tube


Connect to “Drive gas” connector under the
Breathing System with one end of corrugated
tube.

Use the other end of corrugated tube to connect


the “Drive gas” connector located the lfet-side
of machine.

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User Manual

Step 3: Connect breathing tube.


Connect the two tubes onto inspiratory and
expiratory ports respectively.

Step 4: Connect reservior bag.

Connect the reservior bag onto the bag arm


port.

Step 5: Connect integrated sampling tubes.


Make sure every connector inside one end of
Integrated Sampling Tube matches the socket
of the Compositive Gas Pipeline interface, then
push the end of Integrated Sampling Tube until
the bottom of socket, and turn it tightly.

The disassembling procedure is just in reverse.

Connect the other end of Integrated Sampling


Tube to the socket of Breathing System as
above.

Step 6: Connect heater cable.


Align and insert to the Heater interface under
Breathing System with one end of Heater cable.
In the same way, align and insert the other end
(gray) to Heater interface of Outlet module.

6—6
6. Installation and Connection

Step 7: Connect O2 sensor


Loose the O2 sensor plug, and then rotate and
insert the O2 sensor to the corresponding hole
on the Breathing System.

Step 8: Connect O2 sensor cable


Align and insert to the interface of O2 sensor
with one end of O2 sensor cable.

Insert the other end (blue) of O2 sensor cable to


Oxygen interface of Outlet module.

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User Manual

6.4 Connecting Gas and Electricity

WARNING: IEC 60601-1-1 applies both for combination of items of medical


electrical equipment and for combinations of at least one item of
medical electrical equipment with one or more items of non-medical
electrical equipment. Even if there is no functional connection between
the individual pieces of equipment, when they are connected to an
auxiliary mains socket outlet they constitute a medical electrical system.
It is essential that operators are aware of the risks of increased leakage
currents when equipment is connected to an auxiliary mains socket
outlet.
WARNING: The equipment connected to the power outlet will increase electric
current leakage. Test electric current leakage regularly.
WARNING: A malfunction of the central gas supply system may cause more than
one or even all devices connected to it to stop their operation
simultaneously.
CAUTION: Disconnect the anesthetic workstation from the gas supply after use
to prevent contamination or pollution of the pipeline system.
CAUTION: Only the medical gas supply should be used. Other types of gas
supply may contain water, oil or other pollutants.
WARNING: All connectors of gas supply have different dimensions and
structures. It can avoid wrong operation occurs.

6.4.1 AC Inlet
AC Power: 100~240VAC, 50/60Hz; 8A Max.
Fuse: 250V10A, Φ5X20(F)
Power cable is fixed on the mainframe.

Refer to section 8.5 for replacing the fuse.

WARNING Switch the anesthesia machine to backup battery in case of AC failure


alarm, and prompt alarm message displaying on the screen.

6—8
6. Installation and Connection

6.4.2 Aux. Mains Outlet

CAUTION Auxiliary mains socket outlets operator- accessible should be not


more than four when in use ADSIII.
This label displays the voltage of the power supply and the rated ampere value of the circuit
breaker.
Fuse: 250V/2A, Φ5X20 (F)
Maximum current outlet: 1.5A (each); 6A (total)
Refer to section 8.5 for replacing the fuse.

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User Manual

6.4.3 Serial Port


COM A and COM B on the rear of display are isolated RS-232C compitable communication ports,
which can be connected to other medical equipments or IT equipments.
Signal Definition: DCE configuration, which can be connected to a computer directly like modem.
Interface: D-SUB9/Female.
DB/9 Connector Pin Out
Pin # Signal Name Signal Description
2 TXD Transmit Data
3 RXD Receive Data
5 GND Signal Ground / Common
others NC No Connection

6.4.4 Gas Inlet Module

Pressure inlet: 280 to 600kPa


Pipeline connector: DISS (Diameter-indexed safety system) and NIST (non-interchangeable
screw-threaded).
It can prevent wrong connection generating.

6—10
6. Installation and Connection

6.4.5 Cylinder Yoke System

Cylinder connector: PISS (Pin-indexed safety system)


It can prevent wrong connection generating.

WARNING The connecting procedures of O2 and N2O to the rear of the


anesthesia system have been provided. Each has a different
dimension to avoid user’s misoperation. A continuous pressure
monitoring device is installed in the front of the anesthesia system to
monitor each gas that connects with hospital supply pipelines.

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User Manual

6.5 Install gas cylinder (Test high pressure leak)

CAUTION: Do not turn the cylinder valve on when the pipeline gas supply is being
used. The gas supply of the cylinder may be used out in case of pipeline
failure so that the backup supply may be insufficient.

1 Turn the handle T of the cylinder valve clockwise until it is tight. Close the valve of the cylinder
to be changed.

2 Release the yoke piece, then disassemble the cylinder.

3 Remove the valve cap from the new cylinder.

4 Keep the cylinder inlet away from all the objects which could be damaged by the release of
high pressure gas.

5 To clear the cylinder valve of any debris, use the cylinder wrench to briefly open, then close
the cylinder.
6 Install the cylinder.

 Align index pin with the basic hole of the gas cylinder.

 Close yoke piece and screw handle T.

7 Perform the high pressure leak test:


 Disconnect the pipeline gas supply.

 Close flowmeter.

 Open the cylinder.

 Close the cylinder.

 Record the pressure of the cylinder.


 If the pressure of the O2 cylinder drops more than 5000 KPa (725PSi) after one minute,
the high pressure circuit has an unacceptable leak.

 If the pressure of the N2O cylinder drops more than 690 KPa after one minute, the high
pressure circuit has an unacceptable leak.

6—12
6. Installation and Connection

Repairing gas leak

Install a fresh cylinder gasket and tighten the connector.


Repeat this step. Do not use this system in case of continuous gas leak.

6.6 Connect AGSS


Step 1: Install AGSS to the left column.
Find the groove on the left column as shown in
the right picture.

Hold the AGSS with both hands, and then put


the mounting bracket inside the groove until the
limit position.

Step 2: Connect AGSS tube


Connect the EVAC connector under the
Brething System and Φ22 connector of AGSS
with one corrugated tubing (i.e. AGSS tube)

Tight the receiving hose clockwise to the outlet


of AGSS.

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User Manual

6.7 IRMA Probe specification

Model of Sensor: IRMA CO2 or IRMA AX+


Interface : RS232,9600bps
Useful time: Lies on airway adapter,replace it every two weeks.
Accessory: Airway adapter(adult/infant)
Never sterilize or immerse the IRMA airway adapters in liquid.It can
be cleaned using a cloth moistened with ethanol or isopropyl
alcohol.
Principle of IRMA: It is intended to be connected to a patient breathing circuit for
monitoring of inspired/expired gases during anesthesia,recovery
and respiratory care.It may be used in the operating suite,intensive
care unit,patient room and emergency medicine settings for
adult,pediatric and infant patients.
The IRMA probe adopts infrared measurement technology,the
concentrations measurement of different gas in the breathing gas
mixture is based on the fact that the different gas components
absorb infrared light at specific wavelengths.
Integrated with RS-232 digital interface,supply the universal serial
interface communication protocol,easy to connect.

6—14
6. Installation and Connection

6.7.1 Intended use


The IRMA main stream multi-gas probe is intended to be connected to other medical devices for
display of real time and derived monitoring data of CO2,N2O and the anesthetic agents
Halothane,Enflurane,Isoflurane,Sevoflurane and Desflurane.

It is intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases


during anesthesia,recovery and respiratory care.It may be used in the operating suite,intensive
care unit,patient room and emergency medicine settings for adult,pediatric and infant patients.

6.7.2 Technical specification


General
Description Extremely compact infrared mainstream multi-gas
probe.
Dimensions(W×D×H) IRMA CO2
38×37×34mm(1.49”×1.45”× 1.34”)
IRMA AX+:
38×29×31mm(1.49”×1.14”× 1.22”)
Cable length 2.50mm±0.02m
Weight <30g(cable excluded)
Operating temperature IRMA CO2:0~40℃,32~104F
IRMA AX+:10~40℃,50~104F
Storage and IRMA Probe: -20~50℃,-4~122F
transportation
temperature
Operating humdity 10-95%RH,non-condensing
Storage and 5~100%RH,condensing
transportation humidity
IRMA CO2
525 ~ 1200hPa(525 hPa corresponding to an
altitude of 4572m/15000 feet)
IRMA AX+;
700 ~ 1200hPa(700hPa corresponding to an
altitude of 3048m/10000 feet)
Storage and 500to1200hPa
transportation pressure
Mechanical strength Withstands repeated 1m(IRMA CO2 1.8m)drops
on a hard surface.
Complies with requirements for road ambulances
according to prEN1789:2004(clause 6.4) and
requirements for shock and vibration according to
EN ISO 21647:2004(clause 21.102,transport).
Power supply IRMA CO2
4.5~5.5VDC,max1.0W
(power on surge @5V less than 350 mA during
200ms):
IRMA AX+:
4.5~5.5VDC,max1.4W
(power on surge @5V less than 350 mA during
200ms)
Surface temperature IRMA CO2
(at ambient temp.23℃) Max 41℃/106F
IRMA AX+
Max 55℃/131F

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User Manual

Interface Modified RS-232 serial interface operating at


9600bps
Airway adapters Disposable adult/pediatric:
-Adds less than 6ml deadspace
-Pressure drop less than 0.3cm H2O@30LPM
Disposabel infant:
-Adds less than 1ml deadspace
-Pressure drop less than 1.3cm H2O@10LPM

CAUTION: being in a condensing atmosphere,the unit shall be stored for more than
24h in an environment equivalent to the operating humidity.
Data output
Fi and ET Fi and ET are displayed after one breath and
have a continually updated breath average.
IRMA CO2:CO2
IRMA AX+: CO2,N2O,primary and secondary
agents(HAL,ISO,ENF,SEV,DES)
Automatic agent IRMA AX+:Pramary and secondary agent.
identification

Gas analyzer
Calibration Zeroing recommended when changing Airway
adapter
Warm-up time Concentrations are reported and the automatic
agent identification is running within 10 seconds.
Full accuracy within 1minute.
Rise time(@10l/min) CO2≦90s
N2O≦300s
HAL,ISO,ENF,SEV,DES≦300s
Agent identification <20 seconds.(Typically<10 seconds)
time
Total system response <1 second
time

Accuracy specifications-during standard conditions


Range
Gas CO2 AX+ Accuracy
CO2 0~15 0~10 ±(0.2vol%+2% of reading)
15~25 10~20 Unspecified
N2O 0~100 ±(0.2vol%+2% of reading)
HAL,ISO,ENF 0~8 ±(0.15vol%+5% of reading)
8~12 Unspecified
SEV 0~10 ±(0.15vol%+5% of reading)
10~15 Unspecified
DES 0~22 ±(0.15vol%+5% of reading)
22~25 Unspecified
.
CAUTION: Gas concentration reported in units of volume percent.

6—16
6. Installation and Connection

Accuracy specifications-during all conditions


Gas Accuracy
CO2 ±(0.3vol%+4% of reading)
N2O ±(2vol%+5% of reading)
Agents ±(0.2vol%+10% of reading)
CAUTION: The accuracy specification is valid for all specified environment
conditions, except for interference specified in the table “Interfering gas
and vapour effect”below.
CAUTION: The accuracy specification for IRMA AX+ is not valid if more than two
agents are present in the gas mixture.

6.7.3 System assembly instruction


6.7.3.1 Set-up

1. Connect the IRMA connector(RS-232 serial interface) with the COMA below the UI.
2. Snap the IRMA sensor head on top of the IRMA airway adapter.Ii will click into place when
properly seated.

3. A green LED indicates that the IRMA probe is ready for use.

4. Connect IRMA/airway adapter 15mm male connector to the breathing circuit Y-piece.

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User Manual

5. Connect the IRMA/airway adapter 15mm female connector to the patient’s endotracheal tube.

6.7.3.2 Placement of IRMA Probe

When connecting IRMA probe to an infant patient circuit it is important to avoid a direct contact
between the IRMA probe and the patient’s body.
If ,for whatever the reason,the IRMA probe is in direct contact with any parts of the infant’s body an
insulation material shall be placed between the IRMA probe and the body.
WARNING: The IRMA probe is not intended to be in long term skin contact.

6.7.3.3 Pre-use check

Always verigy gas readings and waveforms on the monitor before connecting the airway adapter
to the patient circuit.
Perform the tightness check of the patient circuit with the IRMA probe snapped on the IRMA
airway adapter.

6.7.4 Zeroing procedure

WARNING: Incorrect probe Zeroing will result in false gas readings.

In order to secure high precision of the IRMA probe measurements the following zeroing
recommendations should be followed.
Zeroing is performed by snapping a new IRMA airway adapter onto the IRMA probe,without
connecting the airway adapter to the patient circuit,and then using the host instrument to transmit
a Zero reference command to the IRMA probe.
Special care should be taken to avoid breathing near the airway adapter before or during the
Zeroing procedure.The presence of ambient air(21%O2 and 0%CO2) in the IRMA airway adapter is
of crucial importance for a successful Zeroing.If a “ZERO-REQ” alarm should appear directly after
a Zeroing procedure,the procedure has to be repeated.
Always perform a pre-use check after Zeroing the probe.
IRMA CO2 probes:
Zeroing needs to be performed ONLY when an offset in gas values is observed, or when an
unspecified accuracy message is displayed.
Allow 10 seconds for warm up of the IRMA CO2 probes after power on before proceeding with the
Zeroing Procedure.
Allow the IRMA probe to warm up for at least 10 seconds after changing the IRMA airway adapter
before transmitting the Zero reference command.

6—18
6. Installation and Connection

IRMA AX+probes:
Zeroing should be performed every time the IRMA airway adapter is replaced,or whenever an
offset in gas values or an unspecified gas accuracy messages is diaplayed.
Allow 1 minute for warm up of the IRMA AX+ probes after power on and after changing the IRMA
airway adapter before proceeding with the Zeroing Procedure.The green LED on the probe will be
blinking for approximately 5 seconds while zeroing is in progress.

6.7.5 Alarms
Include a description of the status LED situated on the IRMA probe:
Steady green light System OK
Blinking green light(IRMA AX+) Zeroing in progress
Steady blue light Anesthetic agent present
Steady red light Sensor error
Blinking red light Check adapter

6.7.6 Cleaning
The IRMA probe can be cleaned using a cloth moistened with athanol or isopropyl alcohol.
CAUTION: The IRMA oxygen sensor cell and IRMA airway adapters are non-sterile
devices.Do not autoclave the devices as this will damage them.
CAUTION: Never sterilize or immerse the IRMA probe in liquid.

6.7.7 Preventive maintenance instructions


Gas span check:
Gas readings should be verified at regular intervals with a reference instrument.
Replace the IRMA airway adapter every two months.

6—19
User Manual

6.7.8 Warnings
Include the following warnings:
The IRMA probe is intended for use by authorized and trained medical personnel only.
The IRMA probe must not be used with flammable anesthetic agents.
Disposable IRMA airway adapters shall not be reused.Used disposable airway adapter
shall be disposed of in accordance with local regulations for medical wasts.
Do not use the IRMA Adult/Pediatric airway adapter with infants as the adapter adds 6ml
dead space to the patient circuit.
Do not use the IRMA Infant/Pediatric airway adapter with adults as this may cause
excessive flow resistance.
Measurements can be affected by mobile and RF communications equipment.It should be
assured that the IRMA probe is used in the electromagnetic environment specified in this
manual.
Do not place the IRMA airway adapter between the endotracheal tube and an elbow as this
may allow patient secretions to block the adapter windows and result in incorrect operation.
To keep secretions and moisture from pooling on the windows or oxygen sensor
port,always position the IRMA probe in a vertical position with the LED pointing upwards.
Do not use the IRMA airway adapter with metered dose inhalers or nebulized medications
as this may affect the light transmission of the airway adapter windows.
Incorrect probe zeroing will result in false gas readings.
Replace the adapter if rainout/condensation occurs inside the airway adapter.
The IRMA probe is not intended to be in long term skin contact.

6.7.9 Cautions
Include the following cautions:
Never sterilize or immerse the IRMA probe in liquid.
Do not apply tension to the probe cable.
Do not operate the IRMA probe outside the specified operating temperature environment.

6.7.10 Gas Module


CO2 module is an optional part, ADSIII equipped with CO2 module has been activated before
delivery. Enter gas interface to confirm the activation status of CO2 module. The steps on
activating CO2 module is shown below:
Step 1
Enter SERVICE menu and select GAS
ACTIVATION interface

6—20
6. Installation and Connection

Step 2
Select RETURN to return toSERVICE menu
after confirming the function of CO2 moducle
is activated.

6.7.11 Settings on CO2 Module

NOTE The gas settings can be available only the function of CO2 is activated.
The method on CO2 module setting is as follows:
Step 1
Return to GAS interface and the default
setting for GAS SENSOR is
DISABLED.Press the knob to disable the
function.

Step 2
The system will return to the main interface
within 5 seconds after enabling the gas
sensor function. The gas monitoring
parameters will be shown at the left side of
the main interface.

Step 3
There are two optionsfor CO2 UNIT
NOTE The default setting for CO2
UNIT is mmHg.

6—21
User Manual

Step 4
Select WAVE DISPLAY and there are two
options FLOW and CO2.
The waveform display on the main interface
correspinds to the waveform display setting.
NOTE The default setting for WAVE
DISPLAY is FLOW.
NOTE The system can
automatically memorize the waveform
display setting,and thewaveform can be
retained to the next system operation.

Step 5
Select SENSOR INFO, press the knob to
enter and the gas module’s version
information will appear on the interface.

6.7.12 CO2Module Calibration

NOTE The calibration can be available only if CO2 function is activated.


The method on calibrating CO2 module is as follows:

6—22
6. Installation and Connection

Step 1
Excess GAS interface and enter
CALIBRATION interface.

Step 2
Press the knob to start CO2 CALIBRATION.

Step 3
Follow the on-screen instructions, wait for 1
minute until the status display turns to green.
NOTE The waiting period for all
IRMA modules is 1 minute.

Step 4
Select NEXT to perform CO2calibrating.The
CO2 calibrating interface will appear.
NOTE The indication light for gas
module is at green and flickering status
during calibration.
CALIBRATON SUCCESSFUL will appear if
the calibration is successful, and select
FINISH to finish calibration.
CALIBRATION FAILED will appear if the
calibration fails, and select REPEAT CAL. to
repeat calibration.

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User Manual

6.7.13 Agent Module Calibration

NOTE The calibration can be available only if agent function is activated.


NOTE If CO2 module calibration is successful, agent module calibration will not be
used.
The method on calibrating agent module is as follows:
Step 1
Excess GAS interface and enter
CALIBRATION interface.

Step 2
Press the knob to start AGENTS
CALIBRATION.

Step 3
Follow the on-screen instructions, wait for 1
minute until the status display turns to green.

6.7.12.1.1.1.1 NOTE Disconnect the


module from the Y-piece and
place it into well ventilation
air room is necessary.

NOTE The waiting period for all


TM
IRMA modules is 1 minute.

6—24
6. Installation and Connection

Step 4
Select NEXT to perform agents calibrating.
The agents calibrating interface will appear.
NOTE The indication light for gas
module is at green and flickering status
during calibration.

CALIBRATON SUCCESSFUL will appear if


the calibration is successful, and select
FINISH to finish calibration.
CALIBRATION FAILED will appear if the
calibration fails, and select REPEAT CAL.
to repeat calibration.

Checkout Contents when agent module


calibraton failed:
1) Not put module into well ventilation air
room
2) Not calibrate when Airway adapter is
not installed
3) Not calibrate when Status Area turns
green(less than 1 minute)
4) When Statua Area displays red
“Sensor OFF”, then enter GAS menu,
set GAS Module into Enabled, and
return to calibration interface, operate
anther time after one-minute waiting.
5) Call service please if Gas Module
Comm Fallure or Gas Module Error
appears and tne alarm continues for
more than 1 minute.

6—25
7 Cleaning and Disinfecting
WARNING: Use a cleaning and sterilizing schedule that conforms to your
institution’s sterilization and risk-management policies.
 Refer to the material safety data policy of each agent.

 Refer to the operating and maintaining manual of all the sterilizing


equipments.

 Wear safety gloves and safety goggles. The O2 sensor may leak and
burn (by Chlorine Potassium Oxide) if damaged. Do not inhale fumes.

 Do not inhale fume.

CAUTION: To prevent damage:


 Refer to the data supplied by the manufacturer if there are any
questions about the agent.
 Never use any organic, halogenate or oil base solvent, anesthetic, glass
agent, acestone or other irritant agents.

 Never use any abrasive agent to clean any of the components (i.e. Steel
wool, silver polish or agent).

 Keep liquids far from the electrical components.

 Prevent liquid from entering the equipment.


 Do not immerse the synthetic rubber components more than 15
minutes: any longer will cause inflation, or accelerating aging.

 Only the components marked 134°C are pressure-resistant and


heat-resistant.

 The PH value of the cleaning solution must be from 7.0 to 10.5.

WARNING: Talc, zinc stearate, calcium carbonate, or corn starch that has been
used to prevent tackiness could contaminate a patient’s lung or
esophagus, causing injury.

CAUTION: Never immerse the circuit O2 sensor or flow sensor connector in the
liquid.

Never dispose the circuit O2 sensor connector by using hot press.

Do not clean the inner surface of the flow sensor. Clean the outer
surface by using a damp cloth.

Check if there is damage in the components. Replace if necessary.

7—1
User Manual

7.1 Cleaning and Disinfection of Pre-use


Complete unit Clean the machine’s panel and all surfaces with soft cloth
soaked with the water soluble sterilizing agent.
Sterilize main unit with ultraviolet radiation. Do not use acetic
hyctro peroxide or formaldehyde steaming.
Breathing system components Refer to section 7.2
Breathing System Washing, refer to section 7.4
Bellows Washing, refer to section 7.5.2

7.2 Cleanable Breathing System Components


Corrugated tubing (contacted Designed for using only once, not need to sterilize.
with patient), face mask, Y-piece The waste should be recovered.
connector, L-piece, reservior When to replace these expendable, products with medical
bag level and equal specification should be selected to use.
Corrugated tubing and bag Washing to sterilize
(repetitious)
T-piece Washing to sterilize
Sampling probe and parallel Clean with soap before use of each patient, and then washing
lines of flow in disinfecting solution after airing.

7.3 Absorber Canister


Refer to “Disassembling the Absorber” in the section 6.2.2.

7.3.1 Auto cleaning with Agent or Disinfector


Clean the absorber in the agent or disinfector according to the cleaning procedure.
Put the absorber in the heat-up room with the maximum temperature as 80°C or with the room
temperature.
Higher-level sterilization is recommended if the agent and disinfector cannot sterilize equipment.

7.3.2 Manual Cleaning


Rinse the absorber.
Immerse the absorber completely in the sink with water and agent about three minutes at a
temperature of 40°C.
Rinse the absorber.
Higher-level sterilization must be performed after cleaning by hand.

7—2
7. Cleaning and Disinfecting

7.3.3 Advanced Sterilizing


The absorber must be cleaned before advanced sterilizing.
The absorber can be placed in high temperature and high pressure conditions. The maximum
temperature recommended is 134°C.
Put the soda lime into the absorber after being dried, and then tighten the knob. Clear all soda lime
debris.

7.4 Breathing System Components


Component Cleaning Chemicals Sterilization Maximum
method Cidex Steam temperature
soap water autoclave (°F/°C)
Absorber canister yes yes no ----
Airway pressure gauge no no no ----
APL valve yes yes yes ----
valve cover and valve nut yes yes no ----
Breathing system module yes yes yes 273°F/134°C
(without the above mentioned)
AGSS yes yes no ----
The components in the above table should be rinsed in warm water thoroughly and dried in air
after cleaning or sterilizing.
 Inspiratory valve and expiratory valve

Dismount the cover of the inspiratory and expiratory valves by rotating it counter clockwise, then
clean all parts of them with the gauze soaked with water soluble sterilizing agent, after all parts
cleaned and dried recover it in original integration. Then one must check the leakage and the
movement of the inspiration and expiration valves in accordance with the required regulation and
checking procedure. Please handle all parts with care preventing any damage.
 Absorber module
Either vapouring (not more than 50°C) or immersion sterilization can be used in practice, in case
of immersion all sterilized parts must be dried with the high pressure air or oxygen before reuse.

7.5 Bellows Assembly


This section is about disassembling, assembling, cleaning and sterilizing the bellows assembly.
Read all content of this section before disassembling, assembling, cleaning and sterilizing the
bellows assembly to avoid equipment malfunction and patient injury.

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User Manual

7.5.1 Disassembling Bellows


To disassemble the Bellows:
(To assemble the Bellows, perform the steps in “Disassembling Bellows” in reverse order):
Turn counterclockwise and remove the bellows housing.

7—4
7. Cleaning and Disinfecting

Detach folding gasbag from the base plate.

Remove the sealing ring.

7—5
User Manual

7.5.2 Cleaning and Sterilizing


Follow the machine and sterilizer manufacturer’s cleaning recommendations.
Cleaning
1) Disassembling.

WARNING: Never separate the diaphragm and the valve seat in a pressure-relief
valve.

2) To prevent component damage, clean them lightly. Put the recommended nonenzyme mild
agent used for latex and plastic in hot water.

CAUTION: Do not immerse them more than 15 minutes to prevent inflation or


aging.

3) Rinse using clean hot water, and then dry.

CAUTION: Dry by hanging while fully spread. If moisture is left in the bellows, they
may become tacky.

4) Check the components if they are broken or damp, then perform the assembling and function
test.

5) Connect the bellow assembly, ventilator and breathing system.

6) Perform the preoperative check.

Sterilizing

Cleaning and sterilizing must be performed at the same time. Follow instructions for the common
bellows assembly sterilization methods.

Sterilizing after general patient use:

Clean the inner and outer parts of the bellows assembly in a soap-and-water solution. Rinse
thoroughly in cold water, and dry with soft cloth. Immerse plastic and latex instruments in 70~80%
ethyl alcohol for half an hour. Take them out using the aseptically transmits pliers, then store in
clean containers. Repeat this step before next use. Components made of metal and glass can be
sterilized with high pressure steam. When the steam pressure is increased by the autoclave, the
rising temperature can concrete the bacterium protein rapidly to kill bacteria. In 1.05 kg/cm2 steam
pressure, the temperature rises to 121°C. All bacteria and most sorus can be killed if this
temperature is maintained for 15~25 minutes.

Sterilizing after special infection or infectious patient use:

Open pulmonary TB, pulmonary abscess, pseudomonas, tetanus aeruginosa infection, gas
gangrene or infectious hepatitis is included. Used bellows assembly components must be
completely sterilized according to preliminary and final disposal procedures.
1) Preliminary disposal: Perform in accordance with the isolated disposal stipulation. Collect and
leave all the used bellows assembly components during the operation process in the operating
room. Immerse the bellows assembly components in the 1:1000 benzalkonium bromide or 1~5%
cresol for 30 minutes after finishing the operation.
2) Final disposal: perform the final sterilizing disposal after the bellows assembly components are
processed by the above-mentioned preliminary disposal:

7—6
7. Cleaning and Disinfecting

 Scrub the bellows assembly in a soap-and-water solution. Thoroughly rinse in cold water,
and dry;

 If conditions permit, suffocating the components directly contacted with patients with
formald or oxirane is preferred, or perform immersing sterilization respectively. For
example: the components used by open pulmonary TB patients must be immersed in 3%
cresol for 30 minutes; the components used by tetanus aeruginosa infection patients
must be immersed in 0.2% potassium permanganate for 30 minutes; the components
used by gas gangrene patients must be immersed in 0.1% chlorhexidine for 30 minutes;
the components used by pulmonary abscess patients must be immersed in 0.1%
benzalkonium bromide for 60 minutes; the components used by pseudomonas patients
must be immersed in 0.1% benzalkonium bromide for 120 minutes;

 the components being immersed need to be rinsed by water and dried for next use;

 scrub and rinse the components indirectly contacted with patients with 1-3% phenol
solution or soap-and-water solution and water. Irradiate them by using the ultraviolet ray
for 30 minutes if necessary.

7.5.3 Regular Maintenance

WARNING: Do not perform any tests and repairs when the equipment is being
used to avoid patient injury.
Perform the following check every 30 days to be sure that component worn by use and daily
cleaning are replaced in time.
Test by eyes
Separate the bellows assembly and anesthesia machine
Disassemble the bellows assembly
WARNING: Never separate the diaphragm and the valve seat in a pressure-relief
valve
Check each component carefully to check for cracks, distortion, dissolution, inflation and other
physical changes. Replace them if necessary.
Assemble the bellows assembly, and then perform the leak test.

7—7
8 User Maintenance
WARNING: To avoid fire:
 Use the lubricant approved for anesthesia or O2 equipments’ use.
 Never oil or grease any anesthesia or O2 equipment. In general, oils and
greases oxidize readily, and – the presence of O2 – are highly
flammable.
 All the covers or housings for the system use must be made of static
proof material, as static material may cause fire.

WARNING: Follow sterilizing control and security stipulations because used


equipment may contain and body fluids.
WARNING: Movable components and detachable parts can cause injury. Use
caution when system components and parts are being moved or
replaced.
WARNING: No shock and strong vibration should happen during transportation
because the glass cover of flowmeter is fragile.
WARNING: Disposal of waste or invalidated apparatus must be in accordance with
the relevant policies in local government.

8.1 Repair Policy


Do not use malfunctioning equipment. Make all necessary repairs, or have the equipment serviced
by an authorized our Service Representative. After repair, test the equipment to ensure that it is
functioning properly, in accordance with the manufacturer’s published specifications.
To ensure full reliability, have all repairs and service done by an authorized Representative. If this
is not possible, replacement and maintenance of parts in this manual should be performed by a
competent, trained individual with experience in Anesthesia Systems repair, and appropriate
testing and calibration equipment.

CAUTION: No repair should ever be undertaken or attempted by anyone without


proper qualifications and equipment.
It is recommended that you replace damaged parts with components manufactured or sold by our
company. After any repair work, test the unit to ensure it complies with the manufacturer’s
published specifications.
Contact the nearest our Service Center for service assistance. In all cases, other than where our
warranty is applicable, repairs will be made at our current list price for the replacement part(s) plus
a reasonable labor charge.

8—1
User Manual

8.2 Maintaining Outline and Schedule


The following schedule is a recommended minimum standard based upon normal usage and
environmental conditions. Frequency of maintenance for the equipment should be higher if your
actual schedule is more than the minimum standard.

8.2.1 User maintenance


Minimum Planned maintaining Standard
maintaining Standard
Daily Clean the outer surface.
weekly Perform 21% O2 sensor calibration.
Ventilate the system, open flowmeter, and make sure that the float move
up and down smoothly. It can prevent blocking and clinging.
monthly Perform 100% O2 sensor calibration.
Test leakage of bellows assembly. (refer to section 6.5.2)

When cleaning and Check if any components are broken, and replace or repair them if
installing necessary.
As required Replace new gasket of cylinder gas supply.
Perform flow sensor calibration when flow waveform is unusual.
Replace O2 sensor (one year generally).
Open the drain valve and replace absorbent in the absorber.

8.2.2 Permissive Repairing


Minimum maintaining Planned maintaining Standard
Standard
6 months Test electric current leakage.
6 months Test mechanical safety valve.
12 months Perform the maintenance, checking, testing, calibrating and
replacing of the components stipulated in this manual by
qualified individuals.
Notes: This is the recommended minimum maintaining level.
Perform the local policies if they are equal to or higher than
those in this manual.

8—2
8. User Maintenance

8.2.3 Useful life estimation

CAUTION: The useful life of the following parts should be considered in normal
environment and operating requirements.

Sampling probe and parallel lines 1500 times


Corrugated tubing used repetitiously Not less than 1 year
Power cord, cables, 8 years
sampling cable of O2 sensor
Bellows assembly (except bellows) 1500 times
Drain valve 5000 times
Battery 1 year
Lamp tubes of display 50,000 hours
Pipelines, T-piece 8 years
Main unit 8 years

8.3 Maintaining the Breathing System


Parts that are broken, crushed, worn or distorted must be replaced immediately when cleaning the
breathing system.
Refer to the sections corresponding to reassembly and testing.

8.3.1 Replace O2 sensor

WARNING: Comply with the relevant rules about biohazard when to dispose sensor.
No burning.

Replacement steps:
1 Pull out the connector of sampling cable from O2 sensor.
2 Pull out the O2 sensor from the Breathing system.
3 Replace it with a new one, and connect the sampling cable to O2 sensor.

8.3.2 Calibrate O2 sensor

WARNING: Do not perform the calibration steps when the system connected with
patient.
When to calibrate O2 sensor, ambient pressure must be equal with
monitoring pressure of delivering O2 in the patient circuit.
If operating pressure is not equal with calibrating pressure, the
accuracy of reading may exceed range stated.

8—3
User Manual

8.3.2.1 Calibrate 21% O2 sensor

It will cost more than 3 minutes to perform 21% O2 sensor calibration.


Before performing 100% O2 sensor calibration, 21% O2 sensor calibration must be finished.
Step 1
Press MENU key, the Calibrate menu window appears on the screen., The cursor appears on the
Start Calibration option.

Figure 8-1 O2 Sensor Calibration


Step 2
Press the knob, a new window appears right side.
Perform the operation in accordance with the prompt on the screen.
Disassemble O2 sensor from Breathing System, and put it in the air not less than 3 minutes.

Figure 8-2 O2 Sensor Calibration

8—4
8. User Maintenance

Step 3
Press the knob to perform the calibration.
In the process of calibration, the word “Calibrating” displays on the screen.

Figure 8-3 O2 Sensor Calibration


Calibration successful” will be displayed on the window after the calibration succeed. Then put O2
sensor back to the Breathing System according to the prompt on the window, and perform 100%
calibration.

Figure 8-4 O2 Sensor Calibration

8—5
User Manual

If 21% calibration failure, the word “Calibration failed” displays on the window.
If the calibration failure occurs:
 Ensure the O2 sensor was connected well and exposed in the air minutes,
repeat these steps to calibrate it again.c

 If still failure, check whether the sensor was expired and replace it, then
recalibrate.

Figure 8-5 O2 Sensor Calibration

8.3.2.2 Calibrate 100% O2 sensor

This item only be performed by authorized service engineer.

8—6
8. User Maintenance

8.4 Maintaining O2 sensor


Perform the calibration periodically, interval refer to section 8.2.1.
Recommend that the sensor avoid from high consistence oxygen in free time to extend useful life.

8.4.1 Technical requirements

O2 sensor belongs to expendable, so the user should pay attention to period of validity, and use it
in accordance with performance and requirements.
The technical requirements of O2 sensor used in the Anesthesia machine are the following:
Form and definition of interface: RJ11 interface, 4 way FCC-68 teleconnector
Typical input at 21% concentration: 8 to 15 mV
Accuracy in measurement and full scale error: <3% (0 to 100%)
Operating temperature: 0 to 40℃ (32-104℉), tem perature com pensated
Response time: not more than 15 seconds
Useful life: not less than 12 months
Accordable standard: EN 12598 / ISO 7767

8.4.2 Recommended O2 sensor

Model SV-08A
Manufacturer Sensidyne, Inc.
Response time (second) 7
Useful life (month) 12
Current applied Yes

CAUTION: Only the sensors manufacturer approved can be used.

CAUTION: If the temperature of O2 sensor is lower than dew point of breathing gas,
vapour may coagulate on the surface of sensor, and oxygen
concentration monitored may be lower than practice value.

8—7
User Manual

8.5 Replace the fuses

WARNING: Disconnect from power supply before replacing fuses, otherwise that
can injure operator even death.

WARNING: Replace fuses with only those of the specified type and current rating,
otherwise that can damage the equipment.

CAUTION: The fuse is fragile, so replacement should be carefully. Do not use


excessive force.
Replacing steps:
1. Plug the screwdriver to groove on the end of fuse box.

2. Turn counterclockwise 3 to 5 circles then pull out fuse tubes lightly.

3. Take off fuse tubes.

4. Enclose the new ones.


5. Push fuse tubes to original place gently.

6. Turn clockwise 3 to 5 circles with screwdriver to tighten.


7. Connect mains supply.

8—8
8. User Maintenance

8.6 Maintaining battery


 Specification

Sealed lead acid battery, DC 24V, 5AH.


Charge: 8 hours typically, connecting mains supply effectively, the unit will charge battery
automatically.
Discharge: It will last over 120 minutes generally to use the full-charged battery supply.
 Cautions
The alarm “Low Battery” should be displayed on the screen when the power of battery is
insufficient; There are 15 minutes about until the system shut-off. The user/operator should
connect mains supply to charge battery in time and avoid the system shut-off abnormally.
Do not disassemble battery device without valid authorization.
Do not short-circuit between positive plate and negative plate of battery.
When the time battery powered was less than 60 minutes or used above 3 years, please replace a
new battery.
 Storage

The maintenance of charging should be carried out with interval of 3 months at least if storage of
battery exceeds 3 months.
Stored environment should avoid dampness, high temperature.
If improper maintenance makes battery damage, replace it in time to avoid liquid of battery
corrading the apparatus. Replace the battery, please contact service representatives.

CAUTION: An authorized services representative can replace battery. If not to use


the battery for long-time, please contact service representatives to
disconnect battery. The waste battery should be disposed in
accordance with the local policies.

8—9
9 Alarm and Troubleshooting
WARNING: No repair should ever be undertaken or attempted by anyone without
proper qualifications and equipment.

9.1 About Alarm

CAUTION: If alarm occurs, protect patient safe firstly, and then go to diagnose fault
or service it necessarily.
Alarm messages displays on the top area of display screen. The distance that the operator can
hear the alarm sound or distinguish the priority of alarm is 4 meters at least. And the distance to
see the alarm message is not less than 1 meter at the front of the machine.

Figure 9-1 Alarm message area


The high priority alarms must be disposed immediately.
Priority Volume Silence Prompt Alarm bell
High 5 tones, 2 hurry; 110 seconds Red background, 3 “!” Red, flickering
Periods: 8 seconds Displaying frequency: 2Hz
Medium 3 tones 110 seconds Yellow background, 2 “!” Yellow, flickering
Periods: 10 seconds Displaying frequency:
0.5Hz
Low 2 tones ---- Yellow background, 1 “!” Yellow
Nonrepeat Displaying all the time
until alarm disappears.

CAUTION: There are two alarm display areas, and the array of alarms is
according to priority from high to low. If the priority is the same, the
alarm messages will be shown in the display area in turn.
CAUTION: When alarm silencing, the alarm bell has dashed
“X” on itself.

Also, the alarm volume can be adjusted by user, and alarm volume option is located in Alarm
submenu. It has 10 segments, the adjusting method refers to 3.4.1.
Alarm signal sound pressure range is between 62dB and 75dB which is tested at a distance of 1m.

9—1
User Manual

9.2 Alarm message list

CAUTION: Protect patients in operation; repair the fault after the operation finished.
CAUTION: Operation instruction is not included in the alarm message list.

9.2.1 Technical Alarm


Message Priority Cause of Alarm Trigger Time Machine Operator Action Repair
Mode
When
Checked
(StartUp /
Run)
BDU EEPROM -- Incorrect checksum Immediately upon recognizing Startup Call Service Service Rep needed.
Data Failure during EEProm check failure only Representative
EEPROM IC -- EEPROM cannot Immediately upon recognizing Startup Call Service Service Rep needed.
Failure read/write failure only Representative
WDT Failure -- Incorrect Watchdog state. Immediately upon recognizing Startup Call Service Service Rep needed.
failure only Representative
AD/DA failure -- Incorrect D/A A/D data Immediately upon recognizing Startup Call Service Service Rep needed.
failure only Representative
PEEP failure -- PEEP valve data Immediately upon recognizing StartUp Ventilator failure; Service Rep needed.
incorrect failure Switch to bag mode,
manually bag
(ventilate) patient.
Monitoring is not
available.
Inspiration Valve -- Monitor sensor ZERO Immediately upon recognizing StartUp Ventilator failure; Service Rep needed.
Failure state incorrect. failure Switch to bag mode,
manually bag
(ventilate) patient.
Monitoring is not
available.

9—2
9. Alarm and Troubleshooting

Message Priority Cause of Alarm Trigger Time Machine Operator Action Repair
Mode
When
Checked
(StartUp /
Run)
Vent/ Manual -- Valve state incorrect. Immediately upon recognizing Startup Call Service Service Rep needed.
Valve Failure failure only Representative
Expiration -- Sensor Data incorrect Startup Call Service
Sensor Failure only Representative
O2 Supply High Drive gas pressure is Immediately upon recognizing StartUp Check pipeline gas Replace O2 cylinder.
Failure lower than 2.9 psi ± 15% failure and supply or
Runtime
Power Fail Low The AC Power Fail Alarm The AC Power Fail alarm shall StartUp Check connection Check mains supply
shall occur when there is occur immediately upon and Check fuses Replace
a failure of the AC Mains. recognizing an AC mains Runtime fuses when blown.
failure.
Low Battery Mid With no AC, battery Immediately upon recognizing Runtime Resume AC power Maintain battery
voltage is lower than 22V. failure immediately; 10 periodically, and
minutes remaining ntil ensure it full charged.
shut down, switch to
Bag mode
O2 Sensor High Check the oxygen sensor If oxygen concentration is less Startup and Use external Replace the oxygen
Failure state by the AD input data than 10%, oxygen sensor will Runtime measuring system sensor.
and judge the Oxygen is be considered failed or
failure or not. disconnected.
This alarm is decided by UI
and displayed in any mode
BDU High If the GUI cannot send or If UI does not receive the Startup and Switch to bag mode, Service Rep needed.
Communication received data from the handshaking instruction from RunTime manually
Failure BDU Unit for more than BDU within 2s, BDU bag(ventilate) patient.
0.5s. communication alarm will be Monitoring still
displayed. This alarm is available.
decided by BDU and
displayed in any mode.
Alarm message for 10s, and
ventilator changes to standby.

9—3
User Manual

Message Priority Cause of Alarm Trigger Time Machine Operator Action Repair
Mode
When
Checked
(StartUp /
Run)
Speaker Failure -- Lack of Main alarm StartUp Ventilator normal Please contact eligible
Feadback only working. Abort or service representative.
ignore by user
Software Version -- BDU, UI, and Keyboard Startup Call Service Service Rep needed.
Fail software versions are only Representative
inconsistent with
released set.
Keyboard Low If UI does not receive the Startup and
Communication handshaking instruction Runtime
Failure from keyboard within 3s,
keyboard communication
alarm will be displayed.
This alarm is decided by
UI and displayed in any
mode.
Pressure Sensor -- Pressure Sensor Data Startup Call Service Service Rep needed.
Failure Incorrect. only Representative
Inspiration -- Inspiration Sensor Data Startup Ventilator failure;
Sensor Failure Incorrect only Switch to bag mode,
manually bag
(ventilate) patient.
Monitoring is not
available.

9—4
9. Alarm and Troubleshooting

9.2.2 Functional Alarm


Message Priority Condition Disabled Operator Action Repair
In
Manual
Mode
If the value of airway pressure is greater than 10cmH2O in No Switch to bag mode, If the alarm still exists,
Manual mode and lasts more than 15s, UI generates continuous manually bag (ventilate) please contact eligible
high airway pressure alarm; in other mode, if current value of patient. service representative.
Continuous
High airway pressure>(PEEP value set +10cmH2O and lasts more Check tubes and
Pressure
than 15s, UI generates continuous high airway pressure alarm. sampling lines, and
This alarm is decided by UI and displayed in any mode other dispose block existed.
than standby mode.
In standby mode, airway pressure high alarm detection is not Yes Reset upper limit of ----
needed. Paw.
In Manual mode, after airway pressure high alarm is detected, Check expiratory cycle,
only airway pressure high alarm instruction is sent to UI. and dispose block
In IPPV, PCV, SIMV and PS modes, after airway pressure high existed.
alarm is detected, airway pressure high alarm instruction is sent Check VT settings.
to UI and expiration valve (PEEP) is immediately switched to the Check airway of patient,
value set for parameter PEEP. and dispose block
BDU detects airway pressure in real-time. If airway pressure is existed.
High Airway
High high, airway pressure high alarm instruction will be sent once
Pressure
every 500ms.
UI alarms after receiving the airway pressure high alarm
command and starts 15s timing; if airway pressure high alarm
not received any longer within 15s, the alarm will be cancelled; if
airway pressure high alarm is received again, 15s timing will be
resumed.
This alarm is decided by BDU and displayed in any mode other
than standby mode Exhalation valve blocked.
Machine response: Immediately enter expiratory cycle

9—5
User Manual

Message Priority Condition Disabled Operator Action Repair


In
Manual
Mode
Detected by UI, when freq<4, detection time is 30s; when freq≥4, Yes Reset lower limit of Paw Check the parallel
detection time is 15s. sampling lines.
Low Airway
Mid This alarm is decided by BDU and displayed in any mode other
Pressure
than
standby mode.
FiO2 less than lower limit. No Reset lower limit of ----
Compensation of air or N2O overmuch. FiO2.
Low FiO2 High O2 sensor non-calibrated. Reduce compensation.
O2 sensor failure. Perform the calibration.
Replace O2 sensor.
FiO2 greater than upper limit. No Reset upper limit of ----
High FiO2 Mid
FiO2.
Start 30s timing after each mode switching. When the timing Yes Reset upper limit of MV. ----
ends and if the measured minute ventilation is greater than the
High Minute upper limit of minute ventilation set, the minute ventilation high
Mid
Volume alarm will be displayed.
This alarm is decided by UI and displayed in any mode other
than standby mode.
Start 30s timing after each mode switching. When the timing Yes Reset lower limit of MV. ----
ends and if the measured minute ventilation is less than the Check patient end.
Low Minute upper limit of minute ventilation set, the minute ventilation low
Mid
Volume alarm will be displayed.
This alarm is decided by UI and displayed in any mode other
than standby mode.
In PS mode, if the monitored respiration frequency is higher the N.A. Reset upper limit of f. ----
value set, respiration frequency high alarm will be generated. Examine the patient and
High Breath
Mid This alarm is decided by UI and displayed only in PS mode. confirm independent
Rate
respiration exists or
otherwise.

9—6
9. Alarm and Troubleshooting

Message Priority Condition Disabled Operator Action Repair


In
Manual
Mode
The measured expiratory tidal volume is: Yes
<10mL

For a period of:


>60 seconds (Vent Mode = MANUAL)
or
>35 seconds (Vent Mode=(SIMV or PS) and Breathing
Frequency setting < 6)
or
>30 seconds (all other automatic ventilation modes and
APNEA High Breathing Frequency settings)

The Minute Volume (MV), Tidal Volume (VT) and Breathing


Frequency measurements are blanked during the APNEA
condition and resume after the condition is resolved.

Ventilation mode changes (excluding STANDBY) during an


APNEA condition shall not restart the apnea timing.

Breathing circuit disconnects during automatic ventilation shall


cause an apnea alarm.
If no triggering occurs during the period of minimum expiration N.A.
frequency, PS ventilation will be generated and suffocation
backup ventilation alarm will be sent to UI simultaneously. After
APNEA
Mid that, if triggering occurs, upper machine will send instruction for
Backup
cancelling suffocation backup ventilation alarm will be sent to
upper machine.
This alarm is decided by BDU and displayed only in PS mode.

9—7
User Manual

Message Priority Condition Disabled Operator Action Repair


In
Manual
Mode
In IPPV, PCV and SIMV modes, when current value of N.A.
PEEP>PEEP value set + 5 cmH2O and lasts more than
(24000/current frequency set), UI generates PEEP high alarm; in
High PEEP Mid PS mode, when current value of PEEP>PEEP value set + 5
cmH2O and lasts 30s, UI generates PEEP high alarm.
This alarm is decided by UI, and does not exist in Standby and
Manual modes.
Negative High Negative Airway Pressure of -2cmH2O or less for greater than 4 No
Pressure seconds, UI generates negative pressure alarm.
This alarm is decided by UI and displayed in any mode other
than standby mode.

9—8
9.3 Troubleshooting
Symptom Possible Cause Recommended Action
Breathing System leak APL valve is on Turn APL valve to off
Canister is not sealed very well Reinstall or remove the natrium
calcareousness grains at the joint

Corrugated tubing are broken Replace or reinstall


or the connector loosens
valves loosen Tighten them
Excessive pressure caused APL valve is adjusted Adjust it properly
by manual ventilation incorrectly
APL valve doesn’t work APL valve failure Please contact eligible service
normally representative.
The AC indicator has no Power supply cable is Plug in power supply cable
power, and ventilator does unplugged Turn on power switch
not work Power switch is off Replace with a new one
Fuse is burned
Ventilator stops operating Power supply is interrupted Use manual ventilation
suddenly, indicator light Battery exhaustd
turns off, and sounds alarm
Maximum pressure alarm Breathing System is occluded; Check and adjust Breathing
sounds continuously Patient’s respiratory tract is System
occluded; Check the patient
Maximum pressure setting is Readjust the alarm setting
too low; Recalculate the ventilator
Ventilator parameters changed. parameter
Breathing System leaks; Check the pipeline leak part;
Alarm settings is too high; Reset the alarm settings;
Minimum pressure alarm
Patient’s compliance changes; Check the patient
sounds continuously
Pressure sampling pipe is Check the pressure sampling
disconnected or broken pipe
Pressure sampling pipe is Reconnect the pressure sampling
No indication from the
disconnected; pipe;
airway pressure gauge
Gas supply exhausted. Replace the gas supply
Reconnect the flow sensor;
Flow sensor is unconnected; Check the bellows and replace
Tidal volume readings does The sealing ring of bellows the broken parts, then
not display normally base are broken; reassemble it and carry out
Bellows base are broken; testing procedure according to
section 6.2.5
Gas scavenging port is
Remove the occlusion;
The folding gasbag is occluded
Repair waste gas scavenging
inflated excessively Malfunctioning waste gas
system
scavenging system creates

9—9
User Manual

excessive resistance or
vacuum

9—10
10.1
Pressure
adjustable
valve

Patient
Secretion suction
device

O? operated Flowmeter
valve light Flow Flow
N?O adapter adapter
Mass flow
sensor
Cylinder

Electronic
control
Insp. Exp. Pressure
Flowmeter Vaporizer O? sensor gauge
Schematic diagram

Pressure Check
regulator valve Heating
Fresh
gas Fresh Absorber
AIR Solenoid
Flow sensor gas Container
valve
adapter
Pressure
Cylinder switch
Reversing
valve

Driving
Pressure O? flush gas Bellows
Check regulator
Inlet filter valve
280-600KPa Pressure Proportional Safety Throttle
O? regulator solenoid valve
Check
valve
valve APL
Cylinder
Peep Exhaust
Pressure valve
regulator
Ventilator Breathing
O? bag
AGS
Auxiliary Auxiliary

Figure 10-1 Schematic diagram of system principle


AIR O?
flowmeter flowmeter
Patient
10 Specifications and Operation theory

Gas inlet AGSS Breathing


block ventilator system

10—1
User Manual

10.2 System technical specification


10.2.1 Flow
Flow rate

Gas component Scale ((thin tube)) Scale (thick tube)


O2 0.1~1L/min 1~10L/min
N2O 0.1~1L/min 1~12L/min
Air 0.1~1L/min 1~15L/min
Accuracy: With regard to the flow between 10% of full scale or 300ml/min (higher is preferred) and
full scale under the condition of 20°C, 101.3kPa, flow meter precision is within the ±10% of
indicated values. The precision is 4 degree when the flow is lower than 10% of full scale or
300ml/min (higher is preferred).
Adjust O2 and Nitrous oxide proportionally to ensure the O2 concentration is no less than 25%.
O2 flush: 35 to 50L/min
O2 failure alarm and the associate cut-off device
O2 pressure
O2 failure alarm: 200kPa
N2O cut-off: 50kPa

CAUTION: O2 failure alarm takes precedence of N2O cut-off.

10.2.2 Classification
According to IEC60601-1, ADSIII belongs to the following classifications:
 Class I equipment
 Type B equipment

 General equipment

 Mobile equipment

 Flammable anesthetic cannot be used


 Operate continuously

10—2
10 Specifications and Operation Theory

10.3 Input/Output
10.3.1 Electrical

Voltage: 100~240VA, 50/60Hz


Input power: 2A-8A
Maximum input current: 8A
Fuse at mains supply inlet: 250V/10A, Φ5X20 (F)
Fuse above AMSO: 250V/2A, Φ5X20 (F)
Maximum output current of AMSO: 1.5A (each); 6A (total)
Earth resistance: <0.2Ω

WARNING: Then connection of equipment to the auxiliary mains socket outlets can
increase the patient leakage currents to values exceeding the allowable
limits in the event of a defective protective earth conductor.

10.3.2 Pneumatic
Pipeline supply: O2, Air, N2O
Cylinder supply: O2, N2O
Input pressure at pipeline inlets: 280 to 600kPa
Input pressure at cylinder inlets: 2.5 to 12MPa
Connect to pipeline: DISS-male, DISS-female, NIST (ISO 5359).
All fittings used to connect O2, Air and N2O pipeline gas
supply are all ready.
Connect to cylinder: PISS (pin-indexed safety system)
Reducer: 250kPa
Display pressure: Gauges with color coded
Connect vaporizer: Two Selectatec-type interface vaporizers
Connect to Breathing System Insp. Port connector: Φ22 OD /Φ15 ID
Exp. Port connector: Φ22 OD /Φ15 ID
Breathing System to AGSS: Φ19
Aux. O2 flowmeter: 0-15L/min, barb connector
Aux. Air flowmeter: 0-15L/min, barb connector

WARNING: All gas supplies must be in accordance with medical level.


CAUTION: Pressure at pipeline inlets must be according to 280 to 600kPa when
delivering ceases in the anesthetic gas delivering system.

10—3
User Manual

10.4 Electromagnetic Compatibility


Changing or reassembling this equipment without authorization may cause electromagnetic
compatibility problems. Contact with our company for assistance. Designing and testing this
equipment is in accordance with the following stipulations.
WARNING: using cell phone or other radio radiant equipment near this product may
cause malfunction. Closely monitor the working condition of this
equipment if there is any radio radiant supply nearby.
Using other electrical equipment in this system or nearby may cause interference. Check if the
equipment works normally in these conditions before using on a patient.
Be careful of the following when ADSIII is connected:
Do not put any object which is not in accordance with EN60601-1 in the 1.5M range of patients.
An isolated transformer must be used for alternating current supply (in accordance with IEC60989),
or additional protective ground wires are equipped if all the devices (for medical or non-medical
use) are connected to ADSIII by using signal input/signal output cable.
If a portable all-purpose outlet is used as the alternating current supply, it must be in accordance
with EN60601-1-1 and cannot be put on the floor. Using another portable all-purpose outlet is not
recommended.
Do not connect the non-medical equipment directly to the alternating current outlet on the wall.
Only the alternating current supply of the isolated transformer can be used. Otherwise, the surface
leaking current may exceed the range permitted by EN60601-1 under the normal conditions, and
misoperation may cause injury to patients or operators.
ADSIII is equipped with all-purpose alternating current outlet for connecting other medical
equipments. Do not connect non-medical equipment to these outlets. Otherwise, the surface
leaking current may exceed the range permitted by EN60601-1 under normal conditions and
misoperation may be dangerous to patients or operators.
A complete system current leaking test (according to EN60601-1) must be performed after any
equipment is connected to these outlets.
WARNING: medical electrical equipment operators contact non-medical electrical
equipment and patients at same time. It is dangerous of patients or
operators.

10—4
10 Specifications and Operation Theory

Guidance and manufacture’s declaration – electromagnetic emissions-


for all EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration – electromagnetic emission
The ADSIII Anesthetic machine is intended for use in the electromagnetic environment specified below. The
customer of the user of the ADSIII Anesthetic machine should assure that it is used in such and environment.

Emission test Compliance Electromagnetic environment – guidance


RF emissions The ADSIII Anesthetic machine uses RF energy
CISPR 11 only for its internal function. Therefore, its RF
Group 1 emissions are very low and are not likely to
cause any interference in nearby electronic
equipment.
RF emission The ADSIII Anesthetic machine is suitable for use in
CISPR 11 Class A all establishments, other than domestic
establishments and those directly connected to the
Harmonic emissions public low-voltage power supply network that supplies
Class A buildings used for domestic purposes.
IEC 61000-3-2

Voltage fluctuations/
flicker emissions Complies
IEC 61000-3-3

10—5
User Manual

Guidance and manufacture’s declaration – electromagnetic immunity –


for all EQUIPMENT and SYSTEMS
Guidance and manufacture’s declaration – electromagnetic immunity
The ADSIII Anesthetic machine is intended for use in the electromagnetic environment specified below. The
customer or the user of ADSIII Anesthetic machine should assure that it is used in such an environment.
Electromagnetic
Immunity test IEC 60601 test level Compliance level
environment - guidance
Electrostatic ±6 kV contact ±6 kV contact Floors should be wood,
discharge (ESD) ±8 kV air ±8 kV air concrete or ceramic tile. If floor
IEC 61000-4-2 are covered with synthetic
material, the relative humidity
should be at least 30%.
Electrical fast ±2 kV for power ±2kV for power Mains power quality should be
transient/burst supply lines supply lines that of a typical commercial or
IEC 61000-4-4 hospital environment.
Surge ±1 kV differential ±1 kV differential Mains power quality should be
IEC 61000-4-5 mode mode that of a typical commercial or
±2 kV common mode ±2 kV common hospital environment.
mode
Voltage dips, short <5% UT <5% UT Mains power quality should be
interruptions and (>95% dip in UT) (>95% dip in UT) that of a typical commercial or
voltage variations for 0.5 cycle for 0.5 cycle hospital environment. It should
on power supply be that the ADSIII Anesthetic
input lines 40% UT 40% UT machine be powered from an
IEC 61000-4-11 (60% dip in UT) (60% dip in UT) uninterruptible power supply or
for 5 cycles for 5 cycles a battery.

70% UT 70% UT
(30% dip in UT) (30% dip in UT)
for 25 cycles for 25 cycles

<5% UT <5% UT
(>95% dip in UT) (>95% dip in UT)
for 5 sec for 5 sec
Power frequency 3A/m 3A/m Power frequency magnetic
(50/60Hz) fields
magnetic field Should be at levels
IEC61000-4-8 characteristic of a typical
location in a typical
commercial or hospital
environment.
NOTE UT is the a.c. mains voltage prior to application of the test level.

10—6
10 Specifications and Operation Theory

Guidance and manufacture’s declaration – electromagnetic immunity –


for EQUIPMENT and SYSTEMS that are LIFE-SUPPORTING
Guidance and manufacture’s declaration – electromagnetic immunity
The ADSIII Anesthetic machine is intended for use in the electromagnetic environment specified below. The
customer or the user of ADSIII Anesthetic machine should assure that it is used in such an environment.
Immunity IEC 60601 test Compliance
Electromagnetic environment - guidance
test level level
Portable and mobile RF communications equipment
should be used no closer to any part of the ADSIII
Anesthetic machine, including cables, than the
recommended separation distance calculated from the
equation applicable to the frequency of the transmitter.
Recommended separation distance
 3.5 
Conducted RF 3Vrms 3 Vrms d=  P
IEC 61000-4-6 150 kHz to 80 MHz  V1 
a
outside ISM bands
 12 
10 Vrms 10 Vrms d=  P
150 kHz to 80 MHz V2 
in ISM bands
 12 
Radiated RF 10 V/m 10 V/m d=  P 80 MHz to 800 MHz
IEC 61000-4-3 80 MHz to 2.5 GHz  E1 
 23 
d=  P 800 MHz to 2.5 GHz
 E1 
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended separation
b
distance in metres (m).
Field strengths from fixed RF transmitters, as
c
determined by an electromagnetic site survey, should
be less than the compliance level in each frequency
d
range.
Interference may occur in the vicinity of equipment
marked with the following symbol:

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.
a
The ISM(industrial, scientific and medical) bands between 150kHz and 80MHz are 6.765MHz to 6.795MHz;
13.553 MHz to 14.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.
b
The compliance levels in the ISM frequency bands between 150kHz and 80MHz and in the frequency range
80 MHz to 2.5GHz are intended to decrease the likelihood that mobile/portable communications equipment
could cause interference if it is inadvertently brought into patient areas. For this reason, an additional factor of
10/3 is used in calculating the recommended separation distance for transmitters in these frequency ranges.
c
Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically
with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic
site survey should be considered. If the measured field strength in the location in which the ADSIII Anesthetic
machine is used exceeds the applicable RF compliance level above, the ADSIII Anesthetic machine should
be observed to verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as reorienting or relocating the ADSIII Anesthetic machine.
d
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.

10—7
User Manual

Recommended separation distances between portable and mobile


RF communications equipment and the EQUIPMENT or SYSTEM –
for EQUIPMENT or SYSTEM that are not LIFE-SUPPORTING
Recommended separation distances between
portable and mobile RF communications equipment and the ADSIII Anesthetic machine
The ADSIII Anesthetic machine is intended for use in an electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the ADSIII Anesthetic machine can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the ADSIII Anesthetic machine as recommended below, according
to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter
Rated maximum (m)
output power of 150 kHz to 80 MHz 150 kHz to 80 MHz 80 MHz to 800 800 MHz to 2.5 GHz
transmitter outside ISM bands in ISM bands MHz
 23 
(W)
 3.5   12   12  d=  
P
d =  P d=  P d=  P  E1 
 V1  V2   E1 
0.01 0.1167 0.1200 0.1200 0.2300
0.1 0.3689 0.3795 0.3795 0.7273
1 1.1667 1.2000 1.2000 2.3000
10 3.6893 3.7947 3.7947 7.2732
100 11.6667 12.0000 12.0000 23.0000
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in
metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2 The ISM(industrial, scientific and medical) bands between 150kHz and 80MHz are 6.765MHz to
6.795MHz; 13.553 MHz to 14.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.70 MHz.

NoTE 3 An additional factor of 10/3 is used in calculating the recommended separation distance for transmitters
in the ISM frequency bands between 150kHz and 80 MHz and in the frequency range 80 MHz to 2.5 GHz to
decrease the likelihood that mobile/portable communications equipment could couse interference if it is
inadvertently brought into patient areas.

NOTE 4 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption
and reflection from structures, objects and people.

10—8
10 Specifications and Operation Theory

10.5 Physical specification


All specifications are approximately, maybe changed at any moment without notice.

CAUTION: Do not put ADSIII into the shock environment.


CAUTION: Do not lay the heavy on the top or into the draws.
System Dimensions: 1350mm(H)×650mm(W)×690mm(D)
Weight: 115kg (without vaporizer and cylinder)
Load for 25kg
topplate
Castor 125mm, with breakers on the front castors.
Drawer 130mm(H)×465mm(W)×360mm(D), three drawer are equal
size, with keys on the top drawer.
Display 10.4’ TFT LCD
Cylinder gauge (Air & O2) Scale: 0 to 25MPa (0 to 3500psi). Resolution: 1.25MPa.
Accuracy: ±2.5% of full scale.
Cylinder gauge (N2O) Scale: 0 to 10MPa (0 to 1400psi). Resolution: 0.5MPa.
Accuracy: ±2.5% of full scale.
Pipeline gauge Scale: 0 to 1MPa (0 to 145psi). Resolution: 0.05MPa.
Accuracy: ±2.5% of full scale.
Airway pressure gauge Scale: -20 to 100cmH2O. Resolution: 200Pa.
Accuracy: ±2.5% of full scale.

10.6 Environment Requirements


Temperature Operation: 10 to 40℃
Storage: -10 to 60℃
Relative Humidity Operation: 15 to 90%, non-condensing
Storage: 15 to 90%, non-condensing
Atmospheric pressure Operation: 86 to 106kPa
Storage: 86 to 106kPa

CAUTION: The device should be storaged at the room that is drafty and no
corrosion gas exists.

10—9
User Manual

10.7 Breathing System technical specification


Compensation of fresh Flow compensation range: 1 to 10 L/min
gas
Gas components: O2, N2O, air, anesthetic agent
Absorbent Capacity: 1500 ml (each)
Connection Common Gas Outlet: ISO 5356 connector
Leakage of breathing At pressure of 3 kPa (0.4psi):
system Leakage of flow: ≤150 ml/min
Resistance of breathing At flow of 60L/min:
system Resistance of exhalation: ≤0.6 kPa;
Resistance of inhalation: ≤0.6 kPa.
At flow of 30L/min:
Resistance of exhalation: 2.2 kPa;
Resistance of inhalation: 2.2 kPa.
Patient cycle of small resistance should be used in accordance with
the relevant standard.
Resistance of APL valve At flow of 60L/min, resistance of flow: 0.05 to 3 kPa;
At flow of 30L/min, resistance of flow: 0.1 to 0.5 kPa.
Leakage of connector Resistance of flow: ≤50 ml/min. (APL valve close fully)
Resistance of checkvalve Dryness: ≤0.15 kPa
The pressure generated by a wet unidirectional valve: <0.14 kPa;
The pressure to open a wet unidirectional valve: <0.1 kPa
Compliance of absorber <50 ml/ kPa
Internal volume 2.5L approximately
Rotation 50 degree max.

10—10
10.8

BDU PC104 LCD

Communication Inverter
Power
AC/DC Ampilifer Interface and Power
DC/DC Management

SLA battery Encoder


RS232
Sensors and Valves : & x2
Ins/exp flow keypad
Flowmeter flow
10.8.1 Electrical Schematic Diagram

airway/air/gas
pressure
Ins/exp/cmv valve
Anesthetic Ventilator Specifications

Top light
Back light

Figure 10-2 Operation principle sketch diagram of ventilator


Heater

10—11
10 Specifications and Operation Theory
User Manual

10.8.2 Ventilator performance


Maximum security pressure 90cmH2O
of airway system
Noise of whole unit: Not more than 60dB(A) in normal operation (not including alarm
voice)
Warm-up time More than 5 minutes
Compliance: Not more than 40mL/kPa
Electrical safety: Meet requirements for Class I, type B equipment specified in
EN60601-1 Medical Electrical equipment: Part one: General
requirement for safety.
Minute vloume Max 20L/min
Inspiratory flowrate Max 75L/min

10.8.3 Ventilation Mode Settings

Ventilation mode Adjustable respiratory parameters


IPPV VT, Freq, I:E, TP, PEEP
PCV PT, Freq, I:E, PEEP, TSLOPE
PS Freq, PEEP, ΔP, Trigger, TSLOPE
SIMV VT, Freq, Tinsp, TP, PEEP, ΔP, Trigger, TSLOPE
Manual mode ----

10—12
10 Specifications and Operation Theory

10.8.4 Ventilating parameters settings


Item Range Resolution Default Remark
VT 20~1400mL 10mL 120mL(Child); The max/min Vt output
500mL (Adult) shall be restricted by
max/min ventilating
capacity, i.e. 75L/min
max and 4L/min min.
f 4~60bpm(IPPV, PCV); 1 bpm 20bpm(IPPV, ----
2~60bpm(SIMV) PCV Child);
12bpm(IPPV,
PCV Adult)
4bpm (SIMV
Child & Adult)
I:E 4:1, 3.5:1, 3:1, 2.5:1, 2:1, 0.5 1:2 Unavailable for SIMV &
1.5:1, 1:1, 1:1.5, 1:2, 1:2.5, PS mode.
1:3, 1:3.5, 1:4, 1:4.5, 1:5
TINSP 0.2~5s 0.1s 1s(Child); Only available for SIMV
2s(Adult) mode.
PEEP Off, 3~30cmH2O 1cmH2O Off Unavailable for Standby
mode.
FreqMIN 2~60bpm 1bpm 4bpm(Child); Only available for PS
2bpm(Adult) mode.
TP Off, 5~60% 5% 10% Only available for IPPV,
SIMV+PS mode.
Trigger 1~15L/min 1L/min 2L/min(Child); Only available for SIMV,
3L/min(Adult) PS mode.
PTARGET 5~70cmH2O 1cmH2O 10cmH2O(Child); Only available for PCV
20cmH2O(Adult) mode.
ΔP 3~50cmH2O 1cmH2O 5cmH2O Only available for SIMV
and PS mode.
TSLOPE 0~2s 0.1s 0.5s Available for PCV, SIMV
and PS mode.

10.8.5 Gas dynamics performance


Gas source Anesthetic system
Gas component O2
Rating supply pressure 250kPa
Inlet pressure range 280kPa to 600kPa
Flow valve range 5 to 75L/min
Output Pressure range: 0 to 6kPa; Flow range: 0 to 75L/min

10—13
User Manual

10.8.6 Setting alarm parameters


Item Range Resolution Default Remark
MV Low 0~20L/min 1L/min 0.5L/min(child); Unavailable for Standby mode
1L/min(adult)
MV High 1~25L/min 1L/min 6L/min(child); Unavailable for Standby mode
12L/min(adult)
Paw Low 0~70cmH2O 1cmH2O 8cmH2O(child); Unavailable for Standby mode
10cmH2O(adult)
Paw High 10~80cmH2O 1cmH2O 40cmH2O(child); Unavailable for Standby mode
50cmH2O(adult)
f High 8~60bpm 1bpm 30bpm(child); Only available in PS mode.
18bpm(adult)
FiO2 Low 18%~99% 1% 18% (child); Unavailable for Standby mode
18%(child)
FiO2 High 21%~100% 1% 100%(child); Unavailable for Standby mode
100%(child)
CAUTION: All lower limits of parameters in above table may not be set up the upper
limits, nor may the upper limits be set below the lower limits.
WARNING: A potential hazard can exist if different alarm presets are used for the
same or similar equipment in any single area.
The operator should check that the current alarm preset is appropriate
prior to use on each patient.
Do not set alarm limits to extreme values that can render the alarm
system useless.
Note: In the Alarm submenu, there is a Manual Mode option which has two settings: enabled or
disabled. When disabled choosed, and the ventilation mode change to Manual mode, there are
some prompt information will be shown on the screen all the time.

10—14
10 Specifications and Operation Theory

10.8.7 Monitoring Performance


Item Range Resolution Accuracy
VT 0 ~ 3000mL 1mL ±20%, at least 20mL;
MV 0 ~ 30L 0.1L ±15%
f 0 ~ 99bpm 1bpm ±5%, at least 1bpm
Ppeak -20 ~ 99cmH2O 1cmH2O ±20%, at least 2cmH2O
Pmean -20 ~ 99cmH2O 1cmH2O ±20%, at least 2cmH2O
Pplat -20 ~ 99cmH2O 1cmH2O ±20%, at least 2cmH2O
FiO2 18 ~ 100% 1% ±3%
PEEP -20 ~ 99cmH2O 1cmH2O ±2cmH2O
Battery capacity indication: 100%, 75%, 50%, 25%, 0%.
When using the battery,the icon displays the remainder battery
capacity;when connected with the AC,the icon displays charging.
Paw-t waveform: Pressure monitoring range: -20 to 80cmH2O. Paw-t waveform
display pressure axis varies with the upper alarm limit of Paw:
Range Gain
-10 to 10cmH2O 5cmH2O
-10 to 30cmH2O 10cmH2O
-10 to 80cmH2O 20cmH2O
Time axis is not only a fixed range but aslo same scale for Flow-t
and Paw-t waveforms.
Range: 0 to 15 seconds.
Flow-t waveform: Flow scale: -90 to 90L/min; gain: 45L/min. Time scale: 0 to 15s.
Pressure-Volume loop: Y-Axis: pressure; fixed range: -10 to 50cmH2O; gain: 10cmH2O.
X-Axis: tidal volume; fixed range: 0 to 1250ml; gain: 250ml.
Flow-Volume loop: Y-Axis: flow; fixed range: -90 to 90L/min; gain: 45L/min.
X-Axis: tidal volume, fixed range: -300 to 900ml; gain: 300ml.

10—15
User Manual

10.9 O2 Monitoring Specification


Response time: Not more than 15 seconds
Type of O2 sensor: Chemical fuel cell
Useful life: 12 months (normal operating)
Operational principle: O2 monitoring modules can monitor and display oxygen
concentration of the patient circuit, and contain one oxygen sensor.
The O2 sensor can detect the proportionable voltage on its surface,
generated with partial pressure of O2.
The O2 sensor is chemical fuel cell, and its metal electrode can be
oxidated when oxygen diffuses into it. The current generated from
oxidation proportion O2 partial pressure on the surface of electrode.
The electrode will be used up gradually in oxidation process.
The voltage of sensor would be affected by the temperature of gas
mixture monitored. Thermistor on the shell of sensor will
auto-compensate temperature difference inside the sensor.
Signal processing and circuit analyzing can be used in the O2
monitoring modules. So the signal of O2 sensor could be
transformed to O2 concentration. Besides, the concentration
displays on the screen, and compares with alarm limit value saved,
if the concentration exceeds the limits, alarm should be occurred.

10.10 Latex Use


ADSIII is Latex-free. Latex-free breathing bags and breathing hoses must be used for latex-free
use.

10—16

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